FDA Adverse Event
Other
Summary report: N
CONMED LINVATEC ACL DISPOSABLE KIT 8800
MDR report key: 1419426
·
Received July 21, 2009
Report
- Report Number
- MW5012070
- Event Type
- Other
- Date Received
- July 21, 2009
- Date of Event
- April 25, 2009
- Report Date
- May 4, 2009
- Manufacturer
- ASPEN SURGICAL
- Product Code
- GEI
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
RETURN ON SURGERY FOR REMOVAL OF RETAINED HARDWARE FROM 2009 CASE. GUIDE WIRE BROKEN OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONMED LINVATEC ACL DISPOSABLE KIT 8800 | ACL DISPOSABLE KIT 8800 | GEI | ASPEN SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |