FDA Adverse Event
Injury
Summary report: N
PERFORATOR BIT LARGE 14/11MM
MDR report key: 1133130
·
Received August 22, 2008
Report
- Report Number
- 9616696-2008-00041
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- July 28, 2008
- Report Date
- July 28, 2008
- Manufacturer
- STRYKER IRELAND LTD.
- Product Code
- HBF
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE PERFORATOR BIT, THE PATIENT'S DURA WAS NICKED. IT WAS FURTHER REPORTED THAT A DURA PLASTY WAS CARRIED OUT ON THE PT TO REPAIR THIS NICK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERFORATOR BIT LARGE 14/11MM | DRILLS, BURS, TREPHINES & ACCESSORIES | HBF | STRYKER IRELAND LTD. | 08141017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |