FDA Adverse Event
Injury
Summary report: N
INFERIOR END PLATE MEDIUM-STERILE
MDR report key: 2924586
·
Received January 22, 2013
Report
- Report Number
- 2530088-2013-00052
- Event Type
- Injury
- Date Received
- January 22, 2013
- Report Date
- December 26, 2012
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- MJO
- PMA / PMN Number
- P050010
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS THE DEVICE WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED REGARDING A PATIENT WHO WAS IMPLANTED IN 2008 (EXACT DATE UNKNOWN) WITH A PRODISC LUMBAR, AT LEVELS L5-S1, BELOW A PRIOR FUSION. THE PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 TO REMOVE THE PDL IMPLANT DUE TO THE PDL SUBSIDING BELOW THE PREVIOUS FUSION. THE SURGEON REVISED THE PATIENT WITH FUSION, L5-S1. THIS IS REPORT # 1 OF 3 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29274 | INFERIOR END PLATE MEDIUM-STERILE | INFERIOR END PLATE | MJO | SYNTHES BRANDYWINE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |