BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP PLATE

    MDR report key: 2881363 · Received December 20, 2012

    Report

    Report Number
    2520274-2012-04226
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    DZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS 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

    DURING A MARKET PREFERENCE EVALUATION OF LCP ANKLE SYSTEM FOR A LEFT FIBULA FRACTURE THE SURGEON IMPLANTED A 5 HOLE LATERAL DISTAL FIBULA PLATE AND AN UNKNOWN QUANTITY OF 2.7MM LOCKING SCREWS AND AN UNKNOWN QUANTITY OF 3.5MM CORTEX SCREWS. SURGEON REPORTED THE PLATE SITS OFF THE BONE WHEN IMPLANTED ANTERIORLY. SURGEON ALSO REPORTS DIFFICULTY PLACING THE 2.7MM VA GUIDE TO FIT IN CLOVERLEAF LOCKING HOLE OF THE PLATE. THIS IS 1 OF 2 PARTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP PLATE LCP PLATE DZL SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR SCREWS