FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE MICRO DRILL
MDR report key: 1842007
·
Received August 26, 2010
Report
- Report Number
- 1811755-2010-01050
- Event Type
- Malfunction
- Date Received
- August 26, 2010
- Date of Event
- July 30, 2010
- Report Date
- July 30, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE HAS BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A BLACK FLUID LEAKED OUT OF THE HANDPIECE DURING A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF THE FLUID COMING INTO CONTACT WITH THE SURGICAL SITE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES. THE ACCOUNT WAS UNABLE TO PROVIDE ANY ADDITIONAL INFO OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR CORE MICRO DRILL | POWERED SIMPLE CRANIAL DRILLS, BURRS, TREPHINES, A | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |