FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 1962525
·
Received January 18, 2011
Report
- Report Number
- 1030489-2011-00056
- Event Type
- Injury
- Date Received
- January 18, 2011
- Date of Event
- July 1, 2009
- Report Date
- December 20, 2010
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- KWP
- PMA / PMN Number
- UNKNOWN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) NON-FUSION. NO DEVICES OR APPLICABLE IMAGING STUDIES HAVE BEEN RETURNED TO THE MANUFACTURER. UNABLE TO DETERMINE CAUSE TO THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE POSTERIOR ROD FIXATION AT LEFT L5-S1 AND REPLACE WITH BILATERAL FIXATION L5-S1 AND BONE GRAFT HARVESTED FROM ILIAC CREST. PATIENT REPORTEDLY HAD CONTINUED PAIN AND NON-FUSION. NO HARDWARE DEFECTS WERE NOTED UPON REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | KWP | MEDTRONIC SOFAMOR DANEK USA, INC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00050 YR | Hospitalization| R | ROD, PEDICLE SCREWS, SETSCREWS, BMP-2, ALLOGRAFT |