FDA Adverse Event
Malfunction
Summary report: N
ADULT RADIOLUCENT HORSESHOE HEADREST
MDR report key: 992359
·
Received February 7, 2008
Report
- Report Number
- 3004608878-2008-00006
- Event Type
- Malfunction
- Date Received
- February 7, 2008
- Report Date
- February 7, 2008
- Manufacturer
- INTEGRA LIFESCIENCES CORPORATION
- Product Code
- HBM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INCIDENT. CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORP.
Description of Event or Problem · 1
THE USER FACILITY REPORTS THAT THE DEVICE CAME APART DURING SURGERY. THERE WAS NO PT INJURY REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADULT RADIOLUCENT HORSESHOE HEADREST | HEADREST | HBM | INTEGRA LIFESCIENCES CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |