BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMOND CARPAL FUSION PLATE SCREW

    MDR report key: 1251708 · Received December 3, 2008

    Report

    Report Number
    3003640913-2008-00005
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    October 20, 2008
    Report Date
    December 4, 2008
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    HWC
    PMA / PMN Number
    K030881
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL INSPECTION SHOWED THE SCREW TO BE WITHIN SPECIFICATION. CAUSE OF BREAKAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    EXPLANT OF SBI DIAMOND CARPAL FUSION PLATE, DUE TO BREAKAGE OF HAMATE SCREW AT MID-SHAFT. IMPLANTED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND CARPAL FUSION PLATE SCREW CORTICAL BONE SCREW HWC SMALL BONE INNOVATIONS, INC. 10342

    Patients

    Seq Age Sex Outcome Treatment
    1 Other