FDA Adverse Event
Injury
Summary report: N
EGG/OVAL SHAPED CARBIDE BUR
MDR report key: 1067136
·
Received June 27, 2008
Report
- Report Number
- 9616696-2008-00026
- Event Type
- Injury
- Date Received
- June 27, 2008
- Date of Event
- June 22, 2008
- Report Date
- June 2, 2008
- Manufacturer
- STRYKER INSTRUMENTS CORK
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PODIATRY PROCEDURE, THE BUR WAS CHIPPING. IT WAS REPORTED VIA OUR SALES REP THAT ANTI-BIOTICS WERE ADMINISTERED TO THE PT AFTER THE PROCEDURE. IT WAS REPORTED THAT THE BROKEN PIECES WERE REMOVED WITH SALINE IRRIGATION AND FORCEPS, BUT IT IS UNK IF SMALL PIECES REMAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EGG/OVAL SHAPED CARBIDE BUR | DEVICE DRILLS, BURRS, TREPHINES & ACCESSORIES | HBE | STRYKER INSTRUMENTS CORK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |