BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1040839 · Received May 9, 2008

    Report

    Report Number
    3004608878-2008-00020
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    March 12, 2008
    Report Date
    May 9, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT WAS RECEIVED AND EVALUATED. THE DEVICE WAS PUT UNDER PRESSURE AND THE SLIPPAGE CONDITION COULD NOT BE DUPLICATED. THE 80# TORQUE KNOB TESTED GOOD UNDER PRESSURE. THE RATCHET EXTENSION ARM HAD NO VISIBLE CRACKS AND THE LOCK HAD LITTLE ROTATIONAL MOVEMENT. THE LARGE STARBURST TEETH WERE WORN BUT STILL FUNCTIONAL. THE ROCKER ARM PASSED THE NO NOGO GAUGE. ALL OF THE OTHER COMPONENTS WERE FUNCTIONAL. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE PRODUCT MANUFACTURED UNDER THE REPORTED LOT NUMBER MET ALL RELEASE REQUIREMENTS. THE UNIT WAS PUT UNDER PRESSURE AND THE SLIPPAGE CONDITION COULD NOT BE DUPLICATED. NEITHER FURTHER INVESTIGATION NOR CORRECTIVE ACTION IS DEEMED REQUIRED. INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IN 2008, INTEGRA RECEIVED ADDITIONAL INFORMATION: "UPON CONNECTING THE C-CLAMP TO THE SUPPORT ASSEMBLY (DURING INITIAL POSITIONING), THE HEAD SLIPPED OUT OF THE CLAMP." THE DATE OF INJURY WAS THE PREVIOUS MONTH. THE RN REPORTING THIS INFORMATION ADVISED INTEGRA THAT THE PATIENT SUSTAINED A LACERATION OF LESS THAN ONE INCH ABOVE THE MASTOID. SHE STATED THAT THE LACERATION WAS CLOSED, BUT WAS NOT SURE IF SUTURES OR STAPLES WERE USED. SHE ALSO SAID THAT THERE WERE "NO ISSUES" WITH THE PATIENT FOLLOWING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP NONE HBL INTEGRA LIFESCIENCES CORPORATION 061

    Patients

    Seq Age Sex Outcome Treatment
    1