FDA Adverse Event
Injury
Summary report: N
PFC SIGMARP STB TB IN 5 10.0
MDR report key: 2012542
·
Received February 24, 2011
Report
- Report Number
- 1818910-2011-03012
- Event Type
- Injury
- Date Received
- February 24, 2011
- Date of Event
- January 27, 2011
- Report Date
- January 27, 2011
- Manufacturer
- DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
- Product Code
- NJL
- PMA / PMN Number
- P830055/S113
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIGMARP STB TB IN 5 10.0 | 87NJL | NJL | DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS | NA | 3208888 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |