FDA Adverse Event
Malfunction
Summary report: N
6.5CM ADULT CRANI ATTACHMT
MDR report key: 3970027
·
Received December 11, 2013
Report
- Report Number
- 1045834-2013-14756
- Event Type
- Malfunction
- Date Received
- December 11, 2013
- Date of Event
- May 5, 2011
- Report Date
- June 30, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- K011444
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM USA STATING THAT THE DEVICE OVERHEATED DURING SURGERY. NO INJURY OR MEDICAL INTERVENTION OCCURRED. IT IS UNKNOWN IF SURGICAL DELAY OCCURRED. THERE IS NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 648315 | 6.5CM ADULT CRANI ATTACHMT | HBC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |