FDA Adverse Event
Summary report: N
MAYFIELD MODIFIED SKULL CLAMP
MDR report key: 1230135
·
Received November 7, 2008
Report
- Report Number
- 3004608878-2008-00096
- Date Received
- November 7, 2008
- Report Date
- November 6, 2008
- Manufacturer
- INTEGRA LIFESCIENCES CORPORATION
- Product Code
- HBL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE USER FACILITY REPORTED THAT A PATIENT WAS LACERATED. RECEIVED ADDITIONAL INFO VIA EMAIL FROM THE FACILITY IN 2008. THE PATIENT SUSTAINED A SCALP LACERATION DURING INITIAL POSITIONING. STAPLES WERE USED TO CLOSE THE WOUND. INTEGRA MAYFIELD DISPOSABLE SKULL PAINS WERE USED. AFTER INSPECTING THE PINS, NO DEFICIENCIES WERE NOTED. NO POST-OPERATIVE COMPLICATIONS WERE REPORTED. THE PATIENT'S DIAGNOSIS WAS CERVICAL STENOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAYFIELD MODIFIED SKULL CLAMP | NONE | HBL | INTEGRA LIFESCIENCES CORPORATION | 031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |