FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 2982600
·
Received February 28, 2013
Report
- Report Number
- 1030489-2013-00643
- Event Type
- Injury
- Date Received
- February 28, 2013
- Date of Event
- December 14, 2012
- Report Date
- January 29, 2013
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- PMA / PMN Number
- K981676
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (B)(4). : NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION AT L4-S1 FOR SPONDYLOLISTHESIS. APPROXIMATELY 2 YEARS POST-OP THE PATIENT REPORTED HEARING A NOISE WHILE MOVING. THE PATIENT ALSO REPORTED HAVING PAIN 29 MONTHS POST-OP. FILMS CONFIRMED THAT THE RODS WERE BROKEN BETWEEN L5/S1. THE RODS WERE EXPLANTED 30 MONTHS POST-OP. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87712 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MEDTRONIC SOFAMOR DANEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00015 YR | Required Intervention |