BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSIONBOLT Ø6.5 L110 TAN

    MDR report key: 2900942 · Received January 8, 2013

    Report

    Report Number
    8030965-2013-00057
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Report Date
    December 10, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K081071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED 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

    A HOSPITAL IN (B)(6) REPORTED A PATIENT WAS IMPLANTED WITH A MIDFOOT FUSION BOLT ON AN UNKNOWN DATE. POST OPERATIVE X-RAYS TAKEN ON (B)(6) 2010 SHOWED THE BOLT TO BE MIGRATING DISTALLY. THE BOLT WAS NOT USED WITH ENOUGH SUPPLEMENTAL FIXATION AS RECOMMENDED IN THE SURGICAL TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8777 FUSIONBOLT Ø6.5 L110 TAN FUSIONBOLT Ø6.5 L110 TAN HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1