FDA Adverse Event
Injury
Summary report: N
PFC SIGMARP STB TB IN 3 10.0
MDR report key: 1002274
·
Received February 20, 2008
Report
- Report Number
- 1818910-2008-00683
- Event Type
- Injury
- Date Received
- February 20, 2008
- Date of Event
- January 29, 2008
- Report Date
- January 29, 2008
- Manufacturer
- DEPUY CORK, A DIV. OF DEPUY ORTHOPAEDICS
- Product Code
- NJL
- PMA / PMN Number
- PMA069
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS FOR THE MANUFACTURING LOTS. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED PAIN. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PT REVISED TO ADDRESS PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIGMARP STB TB IN 3 10.0 | 87NJL | NJL | DEPUY CORK, A DIV. OF DEPUY ORTHOPAEDICS | NA | 2333588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |