FDA Adverse Event
Other
Summary report: N
MAYFIELD MODIFIED SKULL CLAMP
MDR report key: 886437
·
Received July 27, 2007
Report
- Report Number
- 3004608878-2007-00018
- Event Type
- Other
- Date Received
- July 27, 2007
- Report Date
- July 27, 2007
- Manufacturer
- INTEGRA LIFESCIENCES CORPORATION
- Product Code
- HBL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
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 THE ROCKER ARM NEEDS TO BE FIXED, A SCALP LACERATION OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAYFIELD MODIFIED SKULL CLAMP | SKULL CLAMP | HBL | INTEGRA LIFESCIENCES CORPORATION | 057 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |