BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEAD RING DRIVE (BRW & CRW)

    MDR report key: 2885671 · Received December 19, 2012

    Report

    Report Number
    1222895-2012-00053
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    HAW
    PMA / PMN Number
    K811452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    HRD CRW HEAD RING DRIVE WELD ON NOTCHED RIM OF THE STAINLESS POSTHOLDER SEPARATED FROM THE DISC. IT WAS RETAINED ONLY BY TWO STAINLESS DOWELS - IF THESE ALSO FAILED THE POST WOULD HAVE ROTATED ON THE POSTHOLDER, ENDANGERING THE PT. THE FAILURE WAS DISCOVERED DURING PRE-SURGERY INSPECTION OF THE HEADRING, AND THE POSTHOLDER WAS REPLACED WITH A SPARE, WITHOUT FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEAD RING DRIVE (BRW & CRW) NA HAW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1