BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1180784 · Received September 22, 2008

    Report

    Report Number
    3004608878-2008-00077
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE USER FACILITY INITIALLY REPORTED A PATIENT LACERATION. THE 80LB TORQUE KNOB DID NOT MAKE IT UP TO 60LB. ADDITIONAL INFORMATION: HOSPITAL RISK MANAGEMENT REPORTED THAT THE PATIENT HAD A CERVICAL DECOMPRESSION C3 THROUGH C7 WITH LATERAL MASS SCREWS BILATERALLY FROM C3 THROUGH C7 AND POSTEROLATERAL FUSION. AFTER APPLICATION OF THE HEAD HOLDER (MAYFIELD CLAMP) IT SLIPPED TWICE. TWO LACERATIONS ON THE RIGHT LATERAL HEAD OCCURRED, ONE 2 INCH AND ONE 1 INCH. BOTH LACERATIONS WERE STAPLED. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP MAYFIELD CLAMP HBL INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1