FDA Adverse Event
Summary report: N
MAYFIELD
MDR report key: 1851588
·
Received September 29, 2010
Report
- Report Number
- 1851588
- Date Received
- September 29, 2010
- Date of Event
- September 22, 2010
- Report Date
- September 27, 2010
- Manufacturer
- INTEGRA LIFESCIENCES
- Product Code
- HBL
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PATIENT BEING PREPARED FOR SURGERY IN MAYFIELD SKULL CLAMP. MAYFIELD PINS PLACED INTO CLAMP AND HEAD. MAYFIELD SET TO 50 LBS OF PRESSURE. WHILE BEING POSITIONED, PATIENT HEAD SLIPPED AND 2 INCH LACERATION NOTED IN LEFT TEMPORAL AREA. CLAMP REMOVED AND PHYSICIAN CLEANED WOUND, SUTURED LACERATION AND APPLIED DRESSING. SECOND MAYFIELD SKULL CLAMP AND PINS APPLIED AS WELL AS 50 LBS OF PRESSURE WAS SET WITHOUT INCIDENT. SURGERY WAS COMPLETED WITHOUT ANY COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAYFIELD | HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) | HBL | INTEGRA LIFESCIENCES | A1059 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR |