FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY FRS SCREW
MDR report key: 747291
·
Received August 1, 2006
Report
- Report Number
- 1818910-2006-02407
- Event Type
- Injury
- Date Received
- August 1, 2006
- Date of Event
- August 1, 2006
- Report Date
- August 1, 2006
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- HWC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVAL WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. PRODUCT INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFO. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADD'L INFO BE RECEIVED, THE INVESTIGATION CAN BE REOPENED.
Description of Event or Problem · 1
THE PATIENT WAS REVISED DUE TO A BROKEN SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY FRS SCREW | TRAUMA DEVICE | HWC | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |