BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 6640972 · Received June 14, 2017

    Report

    Report Number
    3004608878-2017-00187
    Event Type
    Malfunction
    Date Received
    June 14, 2017
    Report Date
    June 1, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    PRE-AMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 07/17/2017. DEVICE HISTORY RECORD REVIEWED FOR SN (B)4) WORK ORDER 2001041 LOT/ 174 MANUFACTURED ON 3/23/2017 SHOW NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. THE DEVICES MANUFACTURED DURING THIS PERIOD PASSED ALL REQUIRED INSPECTION POINTS EXCEPT FOR REJECTED PRODUCT LABELS WHICH WERE REPLACED . PREVIOUS SERVICE HISTORY: (B)(4) REPAIR OF DAMAGED STARBURST TEETH. NO MANUFACTURING OR DESIGN RELATED TREND HAS BEEN IDENTIFIED. ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. THE UNIT WAS SET UP AND TESTED AND PASSED ALL ITEMS EXCEPT THAT THE RATCHET AREA HAD DRAG AS IT PASSES THROUGH THE BASE. HOWEVER, THIS FAILURE ITEM IS NOT RELATED TO THE COMPLAINT ISSUE. THE LOCK HAS ROTATIONAL MOVEMENT, BUT WHEN UNIT IS PROPERLY POSITIONED AND PUT UNDER PRESSURE, UNIT WILL FUNCTION PROPERLY. REPAIR CANNOT DUPLICATE THE RATCHET EXTENSION ARM NOT HOLDING IN PLACE. UNIT NEEDS HELI-COILS ADDED TO LARGE STARBURST THREADS TO ELIMINATE ROTATIONAL MOVEMENT. GENERAL MAINTENANCE AND CLEANING REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, A RATCHET ARM WAS VERY DIFFICULT TO CLOSE. WHEN THE SURGEON WAS READJUSTING THE CLAMP, IT PULLED APART WITHOUT HAVING TO PULL THE PLUNGER TO DISENGAGE THE CLAMP. THE CLAMP WAS SWAPPED OUT. NO INJURY TO PATIENT REPORTED. NO DEATH ALLEGED AND THERE WAS NO SURGICAL DELAY REPORTED. THE CLAMP HAS BEEN PULLED FROM SERVICE ADDITIONAL REQUEST FOR INFORMATION HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420277 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1