FDA Adverse Event
Malfunction
Summary report: N
MAYFIELD MODIFIED SKULL CLAMP
MDR report key: 928283
·
Received October 17, 2007
Report
- Report Number
- 3004608878-2007-00027
- Event Type
- Malfunction
- Date Received
- October 17, 2007
- Report Date
- October 17, 2007
- Manufacturer
- INTEGRA LIFESCIENCES CORPORATION
- Product Code
- HBL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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 CORPORATION.
Description of Event or Problem · 1
THE USER FACILITY REPORTED THAT THE DEVICE WAS SET TO 501 B PF PRESSURE WHEN IT SEEMINGLY LOST PRESSURE CAUSING THE PT'S HEAD TO FLEX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAYFIELD MODIFIED SKULL CLAMP | SKULL CLAMP | HBL | INTEGRA LIFESCIENCES CORPORATION | 071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |