FDA Adverse Event
Injury
Summary report: N
PFC SIGMARP STB TB IN 5 10.0
MDR report key: 1903329
·
Received November 16, 2010
Report
- Report Number
- 1818910-2010-08472
- Event Type
- Injury
- Date Received
- November 16, 2010
- Date of Event
- October 21, 2010
- Report Date
- October 21, 2010
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- NJL
- PMA / PMN Number
- P830055
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED. THE PRODUCT LOT CODE REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE BY LOT CODE WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED INFECTION. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS POSSIBLE INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIGMARP STB TB IN 5 10.0 | 87NJL | NJL | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |