FDA Adverse Event
Malfunction
Summary report: N
EGG/OVAL BUR
MDR report key: 1593028
·
Received January 28, 2010
Report
- Report Number
- 9616696-2010-00099
- Event Type
- Malfunction
- Date Received
- January 28, 2010
- Date of Event
- July 31, 2008
- Report Date
- July 31, 2008
- Manufacturer
- STRYKER IRELAND LTD.
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE BUR SUBJECT TO THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE ALLEGED BREAKAGE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BUR BROKE AT THE SHAFT. NO ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EGG/OVAL BUR | SURGICAL BURS, DRILLS TREPHINES & ACCESSORIES | HBE | STRYKER IRELAND LTD. | 08157017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |