FDA Adverse Event
Injury
Summary report: N
PLYAXL OPN SCRWDRVR- MODULAR TI MOD
MDR report key: 1253073
·
Received December 5, 2008
Report
- Report Number
- 1649384-2008-00577
- Event Type
- Injury
- Date Received
- December 5, 2008
- Date of Event
- October 27, 2008
- Report Date
- December 5, 2008
- Manufacturer
- ABBOTT SPINE
- Product Code
- HXX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT IS AN INSTRUMENT, AND IS NOT IMPLANTABLE. REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.
Description of Event or Problem · 1
IN 2008, THE DISTRIBUTOR REPORTED THAT DURING SURGERY, THE PINS ON THE DRIVER BROKE. THE SURGEON WAS ABLE TO RETRIEVE ALL THE PIECES AND THE SURGEON USED ANOTHER DRIVER IN THE OPERATING ROOM TO FINISH THE CASE AS INTENDED. THERE WAS A SURGICAL DELAY OF TEN MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLYAXL OPN SCRWDRVR- MODULAR TI MOD | INCOMPASS | HXX | ABBOTT SPINE | 43KT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |