FDA Adverse Event
Injury
Summary report: N
PFC SIGMARP STB TB IN 4 15.0
MDR report key: 1222487
·
Received November 5, 2008
Report
- Report Number
- 1818910-2008-04936
- Event Type
- Injury
- Date Received
- November 5, 2008
- Date of Event
- October 13, 2008
- Report Date
- October 13, 2008
- Manufacturer
- DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
- Product Code
- NJL
- PMA / PMN Number
- P830055/S074
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS AGAINST THE MANUFACTURING LOT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED INFECTION. 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 ADDITIONAL INFORMATION BE RECEIVED. THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
THE PATIENT WAS REVISED BECAUSE OF INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIGMARP STB TB IN 4 15.0 | 87NJL | NJL | DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS | NA | 1964605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |