FDA Adverse Event
Malfunction
Summary report: N
LARGE CRANIOTOME, BM
MDR report key: 3960006
·
Received December 13, 2013
Report
- Report Number
- 1045834-2013-14427
- Event Type
- Malfunction
- Date Received
- December 13, 2013
- Report Date
- January 17, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- GFF
- PMA / PMN Number
- K974025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.
Description of Event or Problem · 1
REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE COULD NOT INSERT CUTTER. IT IS UNK IF THE DEVICE WAS BEING USED DURING SURGERY. IT IS UNK IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFO PROVIDED. THE DATE OF THE EVENT WAS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654358 | LARGE CRANIOTOME, BM | GFF | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |