FDA Adverse Event
Injury
Summary report: N
OPEN SCREWDRIVER - MODULAR TI
MDR report key: 1213716
·
Received October 28, 2008
Report
- Report Number
- 1649384-2008-00544
- Event Type
- Injury
- Date Received
- October 28, 2008
- Date of Event
- August 1, 2008
- Report Date
- October 28, 2008
- Manufacturer
- ABBOTT SPINE
- Product Code
- HXX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. EVALUATION IS PENDING.
Description of Event or Problem · 1
ON 03 OCT 2008, THE DISTRIBUTOR REPORTED THAT IN 2008, THE DRIVER BENT AND ONE PRONG BROKE DURING SURGERY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE DISTRIBUTOR ON 21 OCT 2008, THE DISTRIBUTOR REPORTED THAT THIS WAS A REVISION SURGERY FOR REMOVAL OF HARDWARE. THE SURGEON HAD TO RETRIEVE THE BROKEN PRONG FROM THE WOUND. THE SURGEON WAS ABLE TO FINISH THE CASE WITH ANOTHER DRIVER THAT WAS IN THE KIT WITHOUT SURGICAL DELAY OR INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPEN SCREWDRIVER - MODULAR TI | INCOMPASS | HXX | ABBOTT SPINE | 30SW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |