FDA Adverse Event
Malfunction
Summary report: N
GRAY REVISION CEMENT FORCEPS
MDR report key: 56581
·
Received October 2, 1996
Report
- Report Number
- 2219689-1996-00092
- Event Type
- Malfunction
- Date Received
- October 2, 1996
- Date of Event
- August 28, 1996
- Report Date
- October 1, 1996
- Manufacturer
- HOWMEDICA INC.
- Product Code
- LZV
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
WHILE SURGEON WAS REMOVING CEMENT WITH THE CEMENT FORCEPS THE END SNAPPED OFF. THE BROKEN END WAS RETRIEVED AND REMOVED FROM THE CANAL. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT DUE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GRAY REVISION CEMENT FORCEPS | INSTRUMENT | LZV | HOWMEDICA INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Other |