FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 2130791
·
Received June 16, 2011
Report
- Report Number
- 1030489-2011-00742
- Event Type
- Injury
- Date Received
- June 16, 2011
- Date of Event
- January 1, 2011
- Report Date
- May 19, 2011
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- PMA / PMN Number
- K031655
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. A REVIEW OF DEVICE HISTORY RECORDS IS NOT POSSIBLE AT THIS TIME WITHOUT ADDITIONAL DEVICE INFORMATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY AND RECOVERED WELL. THE DOCTOR FOUND A BROKEN SCREW 9 MONTHS POST OP AND RECOMMENDED A CONSERVATIVE TREATMENT. THE PATIENT FELT SYMPTOMS GETTING WORSE AND EXPERIENCED NUMBNESS IN THE LEG RECENTLY. NO OTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MEDTRONIC SOFAMOR DANEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR | Other | RODS, SET SCREWS |