BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 3001608 · Received March 11, 2013

    Report

    Report Number
    3004608878-2013-00044
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 11, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L EXPIRATION DATE: 11/2014. TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A DECOMPRESSION SUBOCCIPITAL WITH C1 LAMINECTOMY AND CRANIOPLASTY WAS IN PROGRESS APPROX 10 MINS WHEN THE PT'S HEAD SLIPPED IN MAYFIELD SKULL PINS. THE PT INCURRED A LACERATION TO LEFT SIDE OF HER HEAD WHICH REQUIRED SUTURES AND STAPLES TO REPAIR THE LACERATION. A REVISION WAS NOT REQUIRED. INTEGRA DISPOSABLE ADULT MAYFIELD SKULL PINS (A1072) WERE USED DURING THE PROCEDURE. THE SKULL PINS USED DURING THE SURGERY WERE PROBABLY ONE OF THESE TWO LOT 1122866 EXP 2014-07 OR 1125363 EXP 2014-11. THE PT'S OUTCOME WAS VERY GOOD, NO OTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101646 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA 1122866 OR 1125363

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention