FDA Adverse Event
Other
Summary report: N
DEPUY
MDR report key: 1193624
·
Received October 9, 2008
Report
- Report Number
- MW5008588
- Event Type
- Other
- Date Received
- October 9, 2008
- Date of Event
- August 8, 2008
- Report Date
- October 8, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS INC.
- Product Code
- HRS
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
FAILED FIXATION DEVICE. HAD BEEN PLACED 3 WEEKS PRIOR FOR RIGHT DISTAL HUMERUS FRACTURE. DEVICE REMOVED AND REPLACED WITH NEW EQUIPMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPUY | LOCKING PLATE | HRS | DEPUY ORTHOPAEDICS INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other |