AFFINITY® ANTERIOR CERVICAL 0381138 Rev. A
CAGE SYSTEM
IMPORTANT MEDICAL INFORMATION ON THE AFFINITY® ANTERIOR CERVICAL CAGE SYSTEM
INFORMATIONS MÉDICALES IMPORTANTES LE SYSTEME DE CAGES AFFINITY® POUR LE RACHIS CERVICAL ANTERIEUR
INFORMACIONES MÉDICAS IMPORTANTES EL SISTEMA DE JAULAS AFFINITY® PARA EL RAQUIS CERVICAL ANTERIOR
WICHTIGE MEDIZINISCHE INFORMATIONEN AFFINITY® CAGE-SYSTEM FÜR DIE ANTERIORE ZERVIKALE WIRBELSÄULE
INFORMAZIONI MEDICHE IMPORTANTI SISTEMA DI GABBIA CERVICALE ANTERIORE AFFINITY®
BELANGRIJKE MEDISCHE INFORMATIE AFFINITY® CAGE SYSTEEM VOOR DE ANTERIEURE CERVICALE WERVELKOLOM
VIGTIGE MEDICINSKE OPLYSNINGER AFFINITY® BURSYSTEM TIL ANTERIOR COLUMNA CERVICALIS
VIKTIG MEDICINSK INFORMATION BURSYSTEMET AFFINITY® FÖR DEN FRÄMRE HALSRYGGEN
VIKTIG MEDISINSK INFORMASJON AFFINITY® BURSYSTEM FOR FREMRE CERVIKAL BRUK
TÄRKEÄ LÄÄKETIETEELLINEN TIEDOTE AFFINITY® ETUPUOLINEN KAULAN HÄKKILAITE
Σημαντικές ιατρικές πληροφορίες ΠΡΟΣΘΙΑ ΑΥΧΕΝΙΚΗ ΦΩΛΕΑ AFFINITY®
INFORMAÇÕES MÉDICAS IMPORTANTES O SISTEMA DE GAIOLAS AFFINITY® PARA A COLUNA CERVICAL ANTERIOR
DŮLEŽITÉ MEDICÍNSKÉ INFORMACE ANTERIORNÍ CERVIKÁLNÍ KLECOVÝ SYSTÉM AFFINITY®
OLULINE MEDITSIINILINE TEAVE AFFINITY® EESMINE KAELAOSA FUSIOONISEADE
FONTOS ORVOSI INFORMÁCIÓK AFFINITY® ANTERIOR NYAKI KALITKARENDSZER
SVARĪGA MEDICĪNISKĀ INFORMĀCIJA APRAKSTS AFFINITY® ANTERIORĀ CERVIKĀLĀ BŪRĪŠA SISTĒMA
SVARBI MEDICININĖ INFORMACIJA AFFINITY® PRIEKINIO PRIĖJIMO CERVIKALINĖ NARVELIŲ SISTEMA
ISTOTNE INFORMACJE MEDYCZNE SYSTEM PRZEDNIEJ KLATKI SZYJNEJ AFFINITY®
DÔLEŽITÉ LEKÁRSKE INFORMÁCIE SYSTÉM ANTERIÓRNEJ CERVIKÁLNEJ KLIETKY AFFINITY®
10/2006
Medtronic B.V. Medtronic Sofamor Danek USA, Inc.
Earl Bakkenstraat 10 1800 Pyramid Place
6422 PJ Heerlen Memphis, TN 38132
The Netherlands Telephone 800 933 2635 (In U.S.A.)
Tel: + 31 45 566 80 00 901 396 3133 (Outside U.S.A.)
Fax 901 396 0356
0123
ENGLISH
IMPORTANT MEDICAL INFORMATION ON THE AFFINITY® CERVICAL CAGE SYSTEM
The following contains important medical information on the AFFINITY® Anterior Cervical Cage System.
DESCRIPTION:
The AFFINITY® Anterior Cervical Cage System consists of a hollow, threaded, tapered metal device which inserts into the intervertebral disc space. The AFFINITY® implants are available in diameters ranging from 6 mm to 12 mm and in
lengths ranging from 12 mm to 14 mm.
The AFFINITY® implants are made from implant grade titanium alloy.
Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog or price list for further information about warranties and limitations of liability.
INDICATIONS:
The AFFINITY® Anterior Cervical Cage System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is
defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies.
AFFINITY® implants are to be used with autogenous bone graft and implanted via an open, anterior approach.
CONTRAINDICATIONS:
The AFFINITY® Anterior Cervical Cage System should not be implanted in patients with an active infection or with an allergy to titanium or titanium alloy.
PRECAUTIONS:
!USA
FOR US AUDIENCES ONLY
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician with appropriate training or experience.
• CAUTION: The AFFINITY® Anterior Cervical Cage System should only be used by surgeons who are experienced in cervical interbody fusion procedures and have undergone adequate training with this device. A lack of adequate
experience and/or training may lead to a higher incidence of adverse events, such as neurological complications.
PHYSICIAN NOTE: Although the physician is the learned intermediary between the company and the patient, the important medical information given in this document should be conveyed to the patient.
ADVERSE EVENTS
The adverse events, as shown in Table 1, were reported from the 202 AFFINITY® device patients and 62 control patients enrolled in multi-center clinical studies. The control treatment was a single level anterior interbody fusion procedure
with iliac crest-derived autogenous bone.
The following table lists the adverse events in alphabetical order. Note: Some patients experienced more than one adverse event.
Surgery Postoperative
1
AFFINITY
Adverse Event
Anatomical/
Technical Difficulty
Cancer 0 0 0 0 0 0 0 0 1 0 1 0 0 0 2 0
Cardio/Vas cular 0 0 3 2 0 0 0 0 0 0 1 3 1 1 5 6
Carpal Tunnel
Syndrome
Dural Tear 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0
Dysphonia/Dysphagia 0 0 5 4 3 0 0 2 0 0 0 0 0 0 8 6
Gastrointes tinal 0 0 7 0 1 1 0 0 0 0 5 1 3 0 16 2
Graft Site Related 0 0 5 2 0 1 0 0 0 0 0 0 0 0 5 3
Implant Displacement/
Loosening/Collapse
Infection 0 0 5 0 1 0 0 0 0 1 1 2 0 2 7 5
Malpositioned Implant 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0
Neck and/or Arm Pain 0 0 2 0 7 0 5 2 5 1 10 2 6 1 35 6
Neurological
2
Upper Body
3
Lower Body
4
Non-Union
Non-Union Pending
Other Pain6 0 0 1 0 1 0 1 1 2 0 5 1 3 2 13 4
Respiratory 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 2
Spinal Event:
Cervical Spine
Thoracic Spine
Lumbar Spine
Subsidence 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0
Trauma 0 0 3 0 1 0 10 1 6 1 5 0 5 4 30 6
Urogenital 0 0 2 4 0 0 0 0 2 0 0 1 1 0 5 5
Vascular I ntra-op 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1
Other7
The most noteworthy adverse events in the AFFINITY® device group were neurological complications and spinal events. A total of 15 upper and lower body neurological events occurred in 15 patients in the AFFINITY® device group. These
events included: 9 events of tingling and/or numbness in arms or hands either with or without associated pain; 2 cases of new myelopathy; 1 event producing leg numbness symptoms; 1 case of hand cramping; 1 Morton’s neuroma of the
foot; and 1 median nerve entrapment which was not carpal tunnel.
A total of 29 spinal events occurred in 27 patients in the AFFINITY® device group. These events included the following: 6 cervical spondyloses, 4 cases of herniated nucleus pulposus in the cervical spine; 3 cervical degenerative disc disease;
1 cervical arthritis; 1 bone spur; 1 thoracic herniated nucleus pulposus and 13 lumbar associated events, such as degenerative disc disease.
In addition, there were 29 patients in the AFFINITY® device group who had 35 reports of neck and/or arm pain. Of the 14 events reported between surgery discharge and 6 months postoperatively, 7 involved neck pain including muscle
cramps or strains, 6 involved shoulder or arm pain including rotator cuff injuries, and 1 involved hand pain.
Of the 10 events occurring between 6 and 12 months postoperatively, 5 involved neck and arm pain, 4 involved shoulder pain including 1 rotator cuff tendonitis, and 1 involved cervical muscle pain and headache. Eleven events occurred
at least 12 months after the initial surgery. Of these, 3 involved shoulder pain, 4 involved neck and/or arm pain, 1 involved arm pain associated with fatigue, 1 involved joint pain in neck, shoulders, back, and hands, 1 involved elbow pain,
and 1 involved thoracic pain.
In addition to the 35 reports of neck/arm pain, Table 1 includes 15 patients who reported hand pain. Of the 50 patients reporting neck/arm/hand pain symptoms, 35 of the complaints could be attributed to the operative or adjacent levels. Of
the 50 patients complaining of postoperative neck, arm and hand symptoms, 10 were considered neck pain failures and 7 were considered arm pain failures according to the success/failure criteria.
5
Control
N=202
N=62
1 3 0 0 0 0 0 0 0 0 0 0 0 0 1 3
0 0 0 0 0 0 1 0 1 0 5 0 0 0 7 0
0 0 0 1 0 2 0 3 0 2 0 1 0 0 0 9
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0 0 3 2 1 0 0 1 0 1 6 1 6 4 16 9
TABLE I - ADVERSE EVENTS
Month)
4
1
0
0
0
0
0
Control
N=62
6 Weeks
(1 Month to 2
Months)
AFFINITY
N=200
3
1
0
0
2
0
0
1
0
Control
0
0
0
0
0
N=58
(1 day to 1
AFFINITY
N=202
1
0
0
0
0
0
0
3 Months
(2 Months to 5
Months)
AFFINITY
Control
N=191
N=58
3
1
1
0
0
0
1
3
3
3
0
1
0
5
6 Months
(5 Months to 9
Months)
AFFINITY
N= 186
0
0
3
1
2
0
5
Control
3
1
2
0
0
0
1
N= 57
12 Months
(9 Months to 19
Months)
AFFINITY
N= 178
2
5
2
0
2
1
1
2
3
5
0
0
0
2
Control
N= 50
24 Months
(or greater)
(19 Months to 48
Months)
AFFINITY
Control
N=174
N= 47
3
4
1
0
3
2
1
0
2
3
0
0
0
1
Total Adverse
Events
AFFINITY Control
17
13
5
2
8
5
4
5
8
15
0
1
1
13
1
Control = Patients receiving the autograft treatment.
2
Neurological adverse events that affected the upper body, i.e., arms, neck, etc.
3
Neurological adverse events that affected the lower body, i.e, legs, feet, etc.
4
Non-union adverse events that have resulted in a second surgery.
5
Non-union adverse events that have not resulted in a second surgery.
6
“Other pain” consists of pain that is not related to the surgery or the treatment area. Examples are bursitis,
knee pain, back pain, migraine headaches.
7
The “Other” adverse event category consists of the following adverse events reported in the clinical trial:
allergy/rash, allergic reaction to chemotherapy, chemotherapy side effects, cholecystectomy, diabetes,
elevated temperature, fibromyalgia, hardware removal, hearing loss and cataracts, hepatomegaly,
Horner’s Syndrome, joint crepitus, low B12 and folate, malpositioned cervical plate, narcotic addiction,
psychological disorder, and toothache.
Table II presents the Bayesian statistical comparison of adverse events between the AFFINITY® device group and the control treatment group.
Table II - Bayesian Comparison of Adverse Events
Adverse Event
Anatomical/Technical Difficulty 0% to 3% 2% to 13%
There is a 95% Probability that
adverse event rates will fall
between the following ranges
AFFINITY®
Device
Control
Cancer 0% to 4% 0% to 6%
Cardio/Vascular 2% to 32% 6% to 52%
Carpal Tunnel Syndrome 2% to 7% 0% to 6%
Dural Tear 0% to 3% 0% to 6%
Dysphonia/Dysphagia 3% to 11% 2% to 15%
Gastrointestinal 6% to 15% 1% to 9%
Graft Site Related 2% to 47% 3% to 54%
Implant Displacement /
Loosening / Collapse
Infection 2% to 10% 0% to 12%
0% to 2% 8% to 25%
Malpositioned Implant 0% to 3% 0% to 6%
Neck and/or Arm Pain 12% to 23% 3% to 16%
Neurological 4% to 12% 26% to 53%
Non-Union (Outcome Pending) 1% to 7% 2% to 21%
Other Pain 3% to 11% 2% to 19%
Respiratory 0% to 2% 1% to 11%
Spinal Event 10% to 23% 7% to 27%
Subsidence 0% to 3% 0% to 6%
Trauma 5% to 47% 6% to 35%
Urogenital 1% to 7% 3% to 23%
Vascular Intraop 0% to 2% 0% to 9%
Other Adverse Event 5% to 13% 5% to 24%
Any Adverse Event 46% to 60% 55% to 81%
Of the 47 patients in the AFFINITY® device group who required a second surgery, 8 had surgery for non-union, 7 had surgery for neck and/or arm pain, 5 had surgery to treat a lumbar condition, 5 required surgery due to trauma, and 3 had
surgery to treat carpal tunnel syndrome. Most of the second surgeries occurred up to and including the 12-Month post-operative interval.
POTENTIAL ADVERSE EVENTS:
The following is a list of potential adverse events which may occur with cervical interbody fusion surgery with the AFFINITY® Anterior Cervical Cage System. Some of these adverse events may have been previously reported in the adverse
events table.
• Bending, breakage, loosening, and/or migration of components
• Foreign body (allergic) reaction
• Tissue or nerve damage
• Post-operative change in spinal curvature, loss of correction, height, and/or reduction
• Infection
• Dural tears
• Neurological system compromise
• Dysphagia/dysphonia
• Scar formation
Some of the adverse events led to surgical interventions subsequent to the clinical trial surgery. These surgical interventions can be classified as revisions, removals,
supplemental fixations, reoperations, and other (see footnotes below Table III for an explanation of these terms). Table III summarizes the secondary surgical interventions
in the AFFINITY® device and control treatment groups in the 12-Month and 24-Month post-operative intervals. Table III also presents the Bayesian statistical comparison
of secondary surgeries between the AFFINITY® device group and the control treatment group.
Clinical Comparison of Secondary Surgeries
Type of Secondary
Surgical Procedure
Type of
Secondary
Surgical
Procedure
Revision
Removal
Supplemental
Fixation
Reoperation
2
Other
1
Control, i.e., patients receiving the autograft treatment
2
Other Second Surgery is any surgical procedure not classified as a revision, removal, supplemental fixation, or a reoperation such as surgeries for hernias,
rotator cuff tears, lumbar adverse events, carpal tunnel syndrome, cervical adverse events that occurred at a different level, etc.
3
Revision: A procedure that adjusts or in any way modifies the original implant configuration.
Removal: A procedure at the involved level that removes one or more components of the original implant configuration without replacement with the same
type of trial device.
Supplemental Fixation: A procedure at the involved level in which additional cervical fixation devices that are not approved as part of the protocol are
placed.
Reoperation: Any surgical procedure at the involved level that is not classified as a Removal, Revision, or Supplemental Fixation, such as a procedure for
wound drainage of the graft site.
Other: Any surgical procedure not classified as a revision, removal, supplemental fixation, or a reoperation, such as surgeries for hernias, rotator cuff tears,
lumbar adverse events, carpal tunnel syndrome, cervical adverse events that occurred at a different level, etc.
4
Some patients experienced more than one second surgery.
Up to 12 Months
(1 day to 19 Months)
AFFINITY®
N=178
3
3
2
5
1
27
Table III - Secondary Surgical Procedures
24 Months
or Later
Control
N=50
1
5
0
0
2
5
(19 Months to 48 Months)
Control
AFFINITY®
N=174
0
3
1
1
4
N=47
2
0
0
0
3
Total Events
AFFINITY®
3
5
6
2
31
There is a 95% Probability that
4
Second Surgery rates will fall
Control
between the following ranges
AFFINITY®
Cage System
1% to 31% 6% to 58%
7
1% to 6% 0% to 6%
0
1% to 6% 0% to 6%
0
0% to 4% 1% to 11%
2
9% to 19% 8% to 30%
8
Bayesian Statistical
Comparison of Second
Surgeries
Control
• Bone fracture
• Non-union (or pseudarthrosis), delayed union, mal-union
• Cessation of any potential growth of the operated portion of the spine. Loss of spinal mobility or function
• Graft donor site complications
• Damage to blood vessels and cardiovascular system compromise
• Gastrointestinal complications
• Damage to internal organs and connective tissue
• Development of respiratory problems
• Incisional complications
• Change in mental status
• Death
Note: Additional surgery may be necessary to correct some of these potential adverse events.
CLINICAL RESULTS:
Study Design and Purpose
A prospective, multi-center, controlled clinical trial of the AFFINITY® Anterior Cervical Cage System was conducted in the United States to determine the safety and effectiveness of the anterior cervical use of the AFFINITY® device in the
treatment of patients with symptomatic cervical disc disease. Investigational patients were treated with the AFFINITY® device filled with autogenous bone derived from the iliac crest. Control patients were treated with iliac crest-derived
autogenous bone.
The effectiveness measures selected for this investigation included whether the treated disc level fused, whether there was relief from neck pain and disability, and whether the neurologic status was maintained or improved. Safety was
evaluated with an analysis of reported adverse events and second surgeries.
Methods
Inclusion criteria for the clinical trial included symptomatic cervical disc disease as noted by intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic
nerve root and/or spinal cord compression documented by diagnostic imaging finding(s); single level involvement from C2-C3 disc to C7-T1 disc; unresponsive to 6 weeks conservative treatment or the presence of progressive symptoms or
signs of nerve root or spinal cord compression in the face of continued non-operative management. Specifically excluded from the clinical trial were patients who had: a previous surgical intervention at the involved spinal level; osteopenia,
osteoporosis, or osteomalacia or metabolic bone disease; instability greater than 3.5 mm translation or 11° of angular motion; overt or active spinal and/or systemic infection; pregnancy ; or a condition which required postoperative medications
that interfere with fusion such as steroids.
Patients were evaluated preoperatively, perioperatively, and postoperatively at 6 weeks, 3, 6, 12, and 24 months. For this clinical trial, overall success was the primary endpoint. Overall success was based on a patient demonstrating fusion,
pain and disability success, neurological success, and no secondary surgical procedure classified as a revision, removal or supplemental fixation. Fusion was based on angular motion and lucent line criteria and was assessed from static and
dynamic radiographs. Pain and disability were measured using the Neck Disability Index. Success was based on the postoperative score being better than the preoperative score by at least 15 points if the preoperative score was at least 30
points or by at least 50% if the preoperative score was less than 30 points. If the preoperative NDI score was zero, the postoperative score also had to be zero for success. Neurological status was evaluated based on sensory, motor, reflex,
and foraminal compression test assessments and success was based on a postoperative maintenance or improvement in condition as compared to the preoperative status.
Statistical Analyses
The results of the clinical study were evaluated using Bayesian statistical methods. All patients involved in the clinical trial of the AFFINITY® Anterior Cervical Cage System and the control group studies were enrolled under the same inclusion/
exclusion criteria. To substantiate the comparability of the two groups, a logistic regression analysis was performed which examined the relationship of all demographic, preoperative medical conditions and preoperative measurements of
effectiveness variables on the overall success results. All preoperative variables were considered as covariate candidates and the five most influential ones (gender, preoperative work status, tobacco use, neurological compression test (F.C.T.)
reaction, and whether a patient had preoperative radicular symptoms) were incorporated into covariate analyses of the outcome parameters, thereby adjusting the posterior probabilities in accordance with their influence. Consequently, based
on this statistical methodology, the most influential prognostic differences between the two treatment groups for demographic and preoperative information were taken into account in assessing the outcome parameters.
A small fraction of the patients did not have their 24-month postoperative evaluations when the results were analyzed. Their 24-month results were predicted from their 12-month outcomes and the relationship established from patients that
had both 12 and 24-month evaluations.
Patient Population
A total of 202 patients were enrolled in the investigational AFFINITY® device treatment group and a total of 62 control patients were entered into clinical studies in both the U.S. and U.K. The mean ages for patients in the AFFINITY® device
and control treatment groups were 44.5 and 50.1 years, respectively. Approximately 52% of the AFFINITY® device patients were males as compared to 57% for the control group. Tobacco use in the control group occurred in approximately
48% of the patients and in 36% of the AFFINITY® device patients. Over 64% of the AFFINITY® device patients were working prior to surgery as compared to a 31% rate for the control patients.
Results
The adjusted posterior means of success probabilities for the primary effectiveness parameters, including overall success, at 24 months postoperative can be found in Table IV.
Table IV – Posterior Means (95% HPD Credible Intervals) of Success
Probabilities for Primary Effectiveness Variables
AFFINITY® Device
Overall Success
Fusion
NDI Pain/Disability
Improvement
Neurological Status
Maintenance or
Improvement
POST APPROVAL STUDY
A total of 95 patients were evaluated at 5 years (60 months) in a post approval study, which was required as a condition of approval for the product. The patient population was obtained from participants in the IDE clinical trial. Based on
criteria from the IDE study, the information obtained on these patients included a description of any additional surgical procedures, radiographic assessment of fusion, and an assessment of pain and function. Table V lists the number
and classification of adverse events that were recorded at the 5 year time point. In addition, twenty-three “other” second surgeries were reported at the 5 year time point, but none of these additional surgical procedures were classified as
“failures.” One patient also had a removal of the AFFINITY™ device due to a non-union that was considered a “failure”, which was reported at the 4 year post-operative timepoint. Also, included in Table VI is a summary of overall success
and the components of the endpoint at the 5 year time point.
Table V – Adverse Events –
5 Year Time Point
Adverse Event
Cancer
Cardio/Vascular 1
Carpal Tunnel
Syndrome
Death 1
Gastrointes tinal 3
Neck and/or Arm Pain 5
Neurological
Non-union
(outcome pending)
Other pain 7
Spinal Event 8
Trauma 5
1
Other
STERILIZATION:
Unless marked sterile and clearly labeled as such in an unopened sterile package provided by the company, all implants and instruments must be sterilized by the hospital prior to use. Remove all packaging materials prior to sterilization. Only
sterile products should be placed in the operative field. Unless specified elsewhere, these products are recommended to be steam sterilized by the hospital using one of the sets of process parameters below:
60 months
54 mos)
(t
AFFINITY® Device
N = 95
2
2
4
1
9
Method Cycle Temperature Exposure Time
24 Months
Success Rate (Range*)
68% (60% to 74%) 61% (48% to 75%)
94% (63% to 97%) 86% (68% to 99%)
75% (68% to 81%) 75% (62% to 87%)
96% (87% to 100%) 78% (45% to 92%)
Table VI – Overall Success Rates –
AFFINITY® Device
Overall Success
Fusion
NDI Pain/Disability
Improvement
Neurological Status
Maintenance or
Improvement
Control
Success Rate (Range*)
5 Year Time Point
* There is a 95% probability that success rates will fall between the ranges listed.
In Table IV, neurological success is defined as success in 3 of the 4 subsections (sensory, motor, reflex, and foraminal compression test) as per the
protocol. If neurological success required successes in 4 of 4 subsections, 13 of 171 AFFINITY® device patients and 16 of 45 control patients would not
be a neurological success. Of the 13 AFFINITY® patients, there were ten patients with reflex deficits and three with sensory deficits. Eight of these deficits
are associated with the operative or adjacent levels.
1
The “Other” adverse event category consists of the following adverse events reported in the clinical trial: subcutaneous mass, corneal
abrasion, left false vocal cord fullness, facial dermatitis, tinnitus, cholecystitis, Dupuytren’s Contracture, breast reduction surgery, and
allergy/rash to medication after breast reduction surgery.
60 Months
72.6% (69/95)
95.8% (91/95)
77.7% (73/94)
97.9% (92/94)
PACKAGING:
Packages for each of the components should be intact upon receipt. If a loaner or consignment system is used, all sets should be carefully
checked for completeness and all components including instruments should be carefully checked to ensure that there is no damage prior
to use. Damaged packages or products should not be used, and should be returned to MEDTRONIC.
CLEANING AND DECONTAMINATION:
Unless just removed from an unopened MEDTRONIC package, all instruments and implants must be disassembled (if applicable) and cleaned
using neutral cleaners before sterilization and introduction into a sterile surgical field or (if applicable) return of the product to MEDTRONIC.
Cleaning and disinfecting of instruments can be performed with aldehyde-free solvents at higher temperatures. Cleaning and decontamination
must include the use of neutral cleaners followed by a deionized water rinse.
Note: certain cleaning solutions such as those containing formalin, glutaraldehyde, bleach and/or other alkaline cleaners may damage some
devices, particularly instruments; these solutions should not be used. Also, many instruments require disassembly before cleaning.
All products should be treated with care. Improper use or handling may lead to damage and possible improper functioning of the device.
Steam Pre-Vacuum 270°F (132°C) 4 Minutes
Steam Gravity 250°F (121°C) 60 Minutes
Steam* Pre-Vacuum* 273°F (134°C)* 20 Minutes*
Steam* Gravity* 273°F (134°C)* 20 Minutes*
Note: Because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization process (e.g., temperatures, times) used for their equipment.
* For outside of the United States, some non-U.S. Health Care Authorities recommend sterilization according to these parameters so as to minimize the potential risk of transmission of Creutzfeldt-Jakob disease, especially of surgical
instruments that could come into contact with the central nervous system.
PRODUCT COMPLAINTS:
Any Health Care Professional (e.g., customer or user of this system of products), who has any complaints or who has experienced any dissatisfaction in the product quality, identity, durability, reliability, safety, effectiveness and/or performance, should
notify the distributor or MEDTRONIC. Further, if any of the implanted spinal system component(s) ever “malfunctions,” (i.e., does not meet any of its performance specifications or otherwise does not perform as intended), or are suspected of doing so,
the distributor should be notified immediately. If any MEDTRONIC product ever “malfunctions” and may have caused or contributed to the death or serious injury of a patient, the distributor should be notified immediately by telephone, fax or written
correspondence. When filing a complaint, please provide the component(s) name and number, lot number(s), your name and address, the nature of the complaint and notification of whether a written report from the distributor is requested.
FURTHER INFORMATION
Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If further information is needed or required, please contact MEDTRONIC.
DEVICE RETRIEVAL EFFORTS:
Should it be necessary to remove an AFFINITY® Anterior Cervical Cage System, please call MEDTRONIC.
©2006 Medtronic Sofamor Danek USA, Inc. All rights reserved.
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