BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES IV STEP SCREW

    MDR report key: 2644694 · Received June 28, 2012

    Report

    Report Number
    3034525-2012-00016
    Event Type
    Injury
    Date Received
    June 28, 2012
    Date of Event
    June 21, 2012
    Report Date
    June 26, 2012
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEONS REPORT OF AN EXCHANGE NAIL SURGERY DUE TO LOOSE NAIL. X-RAY OF PTS IMPLANT SHOWS A BROKEN DISTAL SCREW DUE TO COMPACTION OF NON-UNION, MOST LIKELY CAUSED BY FWB ON NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES IV STEP SCREW SERIES IV STEP SCREW HSB SIGN FRACTURE CARE INTERNATIONAL NAIL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization