BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 3131437 · Received May 10, 2013

    Report

    Report Number
    3034525-2013-00022
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 9, 2013
    Manufacturer
    SIGN FRACTURE CARE INTL.
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CAUSE: NON-UNION WITH FWB FOR AN EXTENDED TIME (TWO YRS). CORRECTIVE ACTION: FRACTURE REPAIR AND HEALING IS ALWAYS UNIQUE TO THE PT AND THE FRACTURE. GUIDANCE ON BEST PRACTICE FOR SIGN NAILING SURGERY IS INCLUDED IN THE SIGN TECHNIQUE MANUAL; HOWEVER NO ONE CAN PREDICT A NON-UNION OR A FAILURE. THEREFORE NO CORRECTIVE ACTION IS INDICATED OR WOULD HELP PREVENT THIS TYPE OF SITUATION FROM HAPPENING AGAIN. NO INDICATION OF PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209339 SIGN IM NAIL INTRAMEDULLARY ROD HSB SIGN FRACTURE CARE INTL. SIGN IM NAIL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization