BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 4634923 · Received March 24, 2015

    Report

    Report Number
    3004608878-2015-00105
    Event Type
    Injury
    Date Received
    March 24, 2015
    Date of Event
    February 27, 2015
    Report Date
    March 2, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORP OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A PATIENT WAS BEING POSITIONED PRONE FOR A CERVICAL FUSION WHEN THE A1059 MAYFIELD MODIFIED SKULL CLAMP SLIPPED. THE PATIENT WAS NOT REPOSITIONED AT ANY TIME PRIOR TO THE SLIPPAGE. A REVISION WAS NOT REQUIRED, HOWEVER, THE PATIENT INCURRED A "SUPERFICIAL" INJURY WHICH REQUIRED WOUND CLOSURE WITH STAPLES. THE PATIENT DID RECOVER. PINS USED DURING THIS PROCEDURE WERE MAYFIELD A1072, DISPOSABLE ADULT. THE LOT NUMBER OF THE SKULL PINS WHICH WERE USED DURING THE SURGERY WAS 1141738.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197675 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORP OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| R