FDA Adverse Event
Malfunction
Summary report: N
MAYFIELD 2000 RADIOLUCENT CLAMP
MDR report key: 2526495
·
Received April 16, 2010
Report
- Report Number
- 2526495
- Event Type
- Malfunction
- Date Received
- April 16, 2010
- Date of Event
- January 7, 2010
- Report Date
- March 15, 2010
- Manufacturer
- INTEGRA LIFE SCIENCES
- Product Code
- HBL
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT WAS IN PRONE POSITION IN OPERATING ROOM AND SURGEON NOTICED PT'S HEAD MOVED. BLEEDING WAS NOTED AND PT WAS REPOSITIONED TO SUPINE THEN TO PRONE POSITION AFTER STAPLING. PROCEDURE: POSTERIOR CERVICAL LAMINECTOMY C4, 5, 6, 7. LENGTH OF TIME IN USE BEFORE THE EVENT OCCURRED: 15 - 20 MINUTES. SKULL PINS USED: ADULT DISPOSABLE. RESULTED IN: 3-4 INCH SCALP LACERATION WHICH REQUIRED STAPLING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAYFIELD 2000 RADIOLUCENT CLAMP | SKULL CLAMP | HBL | INTEGRA LIFE SCIENCES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other |