FDA Adverse Event
Malfunction
Summary report: N
BLACKMAX-NEURO
MDR report key: 3960007
·
Received December 13, 2013
Report
- Report Number
- 1045834-2013-14825
- Event Type
- Malfunction
- Date Received
- December 13, 2013
- Date of Event
- February 1, 2011
- Report Date
- February 1, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBB
- PMA / PMN Number
- K831756
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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 (B)(6) RETURNING THE DEVICE FOR SERVICE. DURING SERVICE DAMAGED BEARINGS WERE FOUND. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654383 | BLACKMAX-NEURO | HBB | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |