Medtronic X640-209 Instructions for Use

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 [phone] (In U.S.A.)
Tel: + 31 45 566 80 00 901 396 3133 (Outside U.S.A.)
Fax [phone]

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