FDA Adverse Event
Malfunction
Summary report: N
WRIGHT MEDICAL TECHNOLOGY, INC
MDR report key: 859304
·
Received May 31, 2007
Report
- Report Number
- MW5002113
- Event Type
- Malfunction
- Date Received
- May 31, 2007
- Date of Event
- April 4, 2007
- Report Date
- May 18, 2007
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC
- Product Code
- HRS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DAMAGED PLATE AND SCREWS REMOVED FROM RIGHT GREAT TOE. MEDICAL REP WAS PRESENT. PT IS 2 MTHS POST OP. DAMAGED PLATS AND SCREWS CONSIST OF: RIGHT SLIMLINE PLATE(1), 2.7MM X 16MM SCREW (1), 2.7MM X 18 MM SCREW (2), 2.7MM X 20 MM SCREW (1), 5CC ALLOMATRIX BONE PUTTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WRIGHT MEDICAL TECHNOLOGY, INC | SLIMLINE PLATE AND HARDWARE | HRS | WRIGHT MEDICAL TECHNOLOGY, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |