BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSIONBOLT Ø6.5 L110 TAN

    MDR report key: 2900130 · Received January 7, 2013

    Report

    Report Number
    8030965-2013-00056
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    January 12, 2010
    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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A MEETING WHILE DISCUSSING MIDFOOT FUSION BOLT CASES IT WAS NOTED X-RAYS TAKEN REVEALED MIGRATION OF THE FUSION BOLT DISTALLY. IT WAS REPORTED THE MIDFOOT FUSION 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
    8283 FUSIONBOLT Ø6.5 L110 TAN FUSIONBOLT HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1