BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD IM NAIL AND INTERLOCKING SCREW

    MDR report key: 2920152 · Received January 8, 2013

    Report

    Report Number
    3034525-2013-00003
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 8, 2013
    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

    DATABASE REPORT SHOWS A BENT IM NAIL WITH A BENT INTERLOCKING SCREW, SURGEON ADDS NO COMMENTS TO THE CASE. REVIEW OF THE PATIENT X-RAYS CONFIRMS THE CONDITION. PATIENT X-RAYS ALSO SHOW A SIGNIFICANT NON-UNION AT THE SITE OF THE BENT NAIL. ADDITIONAL VIEWS SHOW THAT AN EXCHANGE NAIL PROCEDURE WAS PREFORMED. CAUSE: IT APPEARS THAT A NON-UNION SHIFTED, WHICH PLACED STRESS ON THE IM NAIL AT THE SITE OF THE NON-UNION, WHICH CAUSED A BEND AND BENT THE DISTAL INTERLOCKING SCREW. NO INDICATION OF PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8962 STANDARD IM NAIL AND INTERLOCKING SCREW STANDARD IM NAIL AND INTERLOCKING SCREW HSB SIGN FRACTURE CARE INTERNATIONAL IM NAIL & SCREW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization