BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD SWIVEL ADAPTOR

    MDR report key: 2080994 · Received April 13, 2011

    Report

    Report Number
    3004608878-2011-00044
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFO AND EVAL OF THE RETURNED PRODUCTS, THE FINDINGS WERE AS FOLLOWS: THE MAYFIELD SWIVEL ADAPTOR WAS RECEIVED WITH THE SWIVEL SLEEVE TEETH WORN AND NEEDED TO BE REPLACED. THE NYLON WASHERS AND RETAINING RINGS SHOWED WEAR. ALL OTHER COMPONENTS WERE FUNCTIONAL. THE MAYFIELD HORSESHOE HEADREST WAS RECEIVED WITHOUT THE GEL PADS BUT WITH THE FOAM PADS. THE SLIDE BAR NEEDED TO BE REPINED BUT THIS WOULD NOT HAVE CAUSED THE SLIPPAGE. THE NYLON WASHER AND RETAINING RING SHOWED WEAR BUT THIS WOULD NOT HAVE CAUSED THE SLIPPAGE. ALL OTHER COMPONENTS WERE FUNCTIONAL. THE MAYFIELD BASE UNIT WAS RECEIVED WITH THE 6 INCH TRANSITIONAL TEETH WORN AND NEEDED TO BE REPLACED. THE SHOCK CUSHION HAS MOVED FORWARD IN THE HANDLE AND WAS IMPEDING THE 6 INCH TRANSITIONAL FROM GOING INTO THE HANDLE. THE ADJUSTMENT WRENCH WAS BROKEN AND THE STOCK CUSHION AND 1/4 PLASTIC PIN WERE WORN. THE LEFT BRACKET STILL MOVED AFTER BRACKET WAS LOCKED DOWN. THE UNIT IS NOT SAFE AND SHOULD NOT HAVE BEEN USED IN THIS CONDITION. ALL OTHER COMPONENTS WERE FUNCTIONAL. THIS UNIT WAS SENT IN ONLY ONE TIME FOR ROUTINE MAINTENANCE. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAYFIELD SWIVEL ADAPTOR (A1018) ALONG WITH THE ULTRA BASE UNIT (A2101) AND THE MAYFIELD HORSESHOE HEADREST (A1012) SLIPPED DURING A PROCEDURE. THE MAYFIELD SWIVEL ADAPTOR (A1018) SHOWED MOVEMENT AT THE TRANSITION MEMBER WITH PRESSURE. THERE WAS PT CONTACT. IT WAS UNK IF THERE WAS PT INJURY. ADD'L CLINICAL INFO HAS BEEN REQUESTED, HOWEVER, NO NEW ADD'L INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD SWIVEL ADAPTOR SKULL PINS HBL INTEGRA, CINCINNATI

    Patients

    Seq Age Sex Outcome Treatment
    1