BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD TRIAD SKULL CLAMP

    MDR report key: 1931972 · Received November 30, 2010

    Report

    Report Number
    3004608878-2010-00138
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    INTEGRA-OHIO, INC
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFO AND EVAL OF THE RETURNED PRODUCT, THE FINDINGS WERE AS FOLLOWS: THE RETURNED UNIT PASSED ALL FUNCTIONAL TESTING SPECIFICATIONS AS RECEIVED. THE ROOT CAUSE FOR THIS INCIDENT IS NOT RELATED TO THE MANUFACTURE OR THE DESIGN OF PRODUCT.

    Description of Event or Problem · 1

    THE PT WAS INITIALLY PLACED IN A PRONE POSITION WITH "PINONS" FOR A POSTERIOR CERVICAL DECOMPRESSION. IT WAS COMMUNICATED BY THE SURGEON THAT THE CLAMP CAME LOOSE BEFORE THE CASE. AFTER NOTING SOME SLIPPAGE, THE SURGEON USED ANOTHER SKULL CLAMP. THE LENGTH OF TIME IN USE BEFORE THE PROBLEM OCCURRED WAS REPORTED AS FIFTEEN MINUTES. THERE WAS NO PT INJURY. PT OUTCOME WAS REPORTED AS "FINE." INTEGRA DISPOSABLE ADULT PINS WERE USED. NO STEREOTAXY DEVICE WAS USED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD TRIAD SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA-OHIO, INC

    Patients

    Seq Age Sex Outcome Treatment
    1