FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 1082262
·
Received July 24, 2008
Report
- Report Number
- 1030489-2008-00363
- Event Type
- Injury
- Date Received
- July 24, 2008
- Date of Event
- June 27, 2008
- Report Date
- June 30, 2008
- Manufacturer
- WARSAW ORTHOPAEDIC INC.
- Product Code
- KWP
- PMA / PMN Number
- K981676
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EIGHT SETSCREWS WERE RETURNED TO MEDTRONIC FOR EVALUATION AS WELL AS ONE POST-OP LATERAL X-RAY. VISUAL EXAMINATION OF THE RETURNED IMPLANTS FOUND THAT A FEW OF THE SETSCREWS REVEAL MARKINGS THAT MAY INDICATE THE ROD MAY NOT HAVE BEEN FULLY SEATED. X-RAY EXAMINATION CONFIRMED THE SETSCREWS BACKED OUT AT THE MOST CEPHALAD LEVEL.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A POST-OP FOLLOW-UP VISIT, X-RAYS TAKEN IN 2008 REVEALED 2 OF THE 8 IMPLANTED SETSCREWS HAD BACKED OUT OF THE SCREWS. THE PT HAS NO SYMPTOMS. THE PT UNDERWENT A REVISION SURGERY TO REMOVE THE RODS AND SETSCREWS. NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | SETSCREW | KWP | WARSAW ORTHOPAEDIC INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |