FDA Adverse Event
Malfunction
Summary report: N
PATELLA CLAMP
MDR report key: 1932832
·
Received December 2, 2010
Report
- Report Number
- 2249697-2010-01654
- Event Type
- Malfunction
- Date Received
- December 2, 2010
- Date of Event
- November 10, 2010
- Report Date
- November 10, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
"IT WAS REPORTED THAT THE PATELLA CLAMP WOULD NOT LOCK. IT WAS REPORTED THAT THE LOCKING MECHANISM WAS LOOSE AND THAT THE SURGEON USED HIS HAND TO HOLD THE UNIT IN PLACE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PATELLA CLAMP | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | CZL16B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |