FDA Adverse Event
Injury
Summary report: N
5.0MM DIA TPRD HD PER SCRW 45
MDR report key: 1162732
·
Received September 15, 2008
Report
- Report Number
- 1818910-2008-03730
- Event Type
- Injury
- Date Received
- September 15, 2008
- Date of Event
- August 19, 2008
- Report Date
- August 19, 2008
- Manufacturer
- DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
- Product Code
- JDL
- PMA / PMN Number
- K861979
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR STERILIZATION CERTIFICATIONS DID NOT REVEAL ANY RELATED DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR/CONTRIBUTION REGARDING THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS INFECTION (RIGHT SIDE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5.0MM DIA TPRD HD PER SCRW 45 | 87JDL | JDL | DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. | NA | B5JG54000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |