FDA Adverse Event
Malfunction
Summary report: N
6.5CM ADULT CRANI ATTACHMT
MDR report key: 3955286
·
Received December 13, 2013
Report
- Report Number
- 1045834-2013-07900
- Event Type
- Malfunction
- Date Received
- December 13, 2013
- Report Date
- October 7, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- K011444
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, 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 ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.
Description of Event or Problem · 1
REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE HAD A "NEURO-TIP BENT/BROKEN". THE DEVICE WAS USED DURING A SURGICAL PROCEDURE. IT IS KNOWN THAT THERE WAS NO USER OR PT INJURY. IT IS UNK IF MEDICAL INTERVENTION WAS REPORTED. THERE WAS NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 653750 | 6.5CM ADULT CRANI ATTACHMT | HBC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |