BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREMER MAYFIELD ADAPTOR

    MDR report key: 2480687 · Received March 6, 2012

    Report

    Report Number
    1526439-2012-00045
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Date of Event
    February 15, 2012
    Report Date
    March 6, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    IQK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED AND NO CONCLUSIONS CAN BE MADE. DEVICE IS A REUSABLE CLAMP AND IT IS POSSIBLE THAT WEAR / FATIGUE OVER THE LIFE OF THE DEVICE CONTRIBUTED TO THIS EVENT. A REVIEW OF RECORDS FOUND NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS PRODUCT TO DATE. THIS IS AN ISOLATED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ADAPTOR (TABLE CLAMP) USED TO HOLD THE HALO CROWN BROKE DURING APPLICATION WHEN THE PATIENT WAS IN TRACTION. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. CONTACT CONFORMED THAT THE DEVICE BROKE WHILE IT WAS ATTACHED TO THE PATIENT, AND THAT THE PROBLEM DID NOT RESULT IN ANY ADVERSE PATIENT OUTCOME. AS THE PATIENT IS IN A COMPROMISED POSITION AT THIS POINT AN EVENT OF THIS NATURE COULD POSSIBLY RESULT IN AN ADVERSE PATIENT OUTCOME. AS SUCH AN MDR IS FILED TO DOCUMENT THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREMER MAYFIELD ADAPTOR ORTHOSIS, CERVICAL IQK DEPUY RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1