BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD IM NAIL

    MDR report key: 2893966 · Received December 21, 2012

    Report

    Report Number
    3034525-2012-00046
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 21, 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

    REVIEW OF SURGEON'S DATABASE REPORT SHOWS NO COMMENTS RELATIVE TO SURGERY ISSUES, HOWEVER, THE PRE AND POST OP PT X-RAYS SHOW A BENT IM NAIL, WHICH HAS BEEN REPLACED BY EXCHANGE NAIL SURGERY. REVIEW OF E-MAIL SYSTEM FOUND NO ADDITIONAL INFO ON THE CASE. CAUSE: THE CAUSE APPEARS TO BE POSSIBLE EXTERNAL STRESS PLACED ON THE AREA OF A NON-UNION FRACTURE SITE CAUSING A BEND IN THE IMPLANTED IM NAIL. NO INDICATION OF PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD IM NAIL STANDARD IM NAIL HSB SIGN FRACTURE CARE INTERNATIONAL STANDARD IM NAIL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization