FDA Adverse Event
Malfunction
Summary report: N
CLP HIP INSTRUMENTATION
MDR report key: 1220355
·
Received October 31, 2008
Report
- Report Number
- 1644408-2008-00378
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- October 10, 2008
- Report Date
- October 13, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- HWB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
TRYING TO EXTRACT STEM AND HOOK OF CLP STEM EXTRACTOR BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLP HIP INSTRUMENTATION | EXTRACTION HOOK | HWB | ENCORE MEDICAL, L.P. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |