BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2010667 · Received February 25, 2011

    Report

    Report Number
    2520274-2011-00061
    Event Type
    Injury
    Date Received
    February 25, 2011
    Report Date
    February 4, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. MANUFACTURE SITE AND MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER. COULD NOT BE DETERMINED WITHOUT A CATALOG NUMBER. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    ATTORNEY ADVISED, A PT FELL AT WORK AND FRACTURED HIS LEFT UPPER ARM. UNK PLATE AND SCREWS WERE IMPLANTED. PT EXPERIENCED POST OP PAIN. SUBSEQUENT VISIT TO THE SURGEON WITH FILMS SHOW 1 SCREW BROKEN AND 1 SCREW LOOSENED/BACKED OUT. SURGEON ELECTED TO IMMOBILIZE THE ARM TO TRY TO PROMOTE HEALING WITHOUT SURGERY AND ALSO USE ELECTRICAL STIMULATION TO FOSTER BONE GROWTH. THERE WAS A CONTINUANCE OF THE INSTABILITY AND THE HEALING WAS UNSATISFACTORY. PT WAS REVISED WITH REMOVAL OF HARDWARE AND IMPLANTATION OF POSSIBLE LARGER HARDWARE. THIS IS THE REPORT #2 OF 2 ON THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW SCREW HWC SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention PLATE