BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES IV STEP SCREW

    MDR report key: 3059589 · Received April 12, 2013

    Report

    Report Number
    3034525-2013-00017
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 4, 2013
    Report Date
    April 12, 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

    SURGEONS DATABASE REPORT STATES THAT PT PRESENTED WITH A THREE YEAR OLD IM NAIL IMPLANT WITH PAIN AT KNEE AND FRACTURE SITE. REVIEWED PT X-RAYS WHICH SHOW THAT THE IMPLANT MAY HAVE MIGRATED TOWARD THE KNEE AND SOME SLIGHT DISPLACEMENT OF INTERLOCKING SCREWS. PT X-RAYS ALSO SHOW A NON-UNION OF THE F/X SITE. THE SURGEON PERFORMED AN EXCHANGE SURGERY TO REPLACE THE IM NAIL. NO INDICATION OF PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157701 SERIES IV STEP SCREW SERIES IV STEP SCREW HSB SIGN FRACTURE CARE INTERNATIONAL STEP SCREW UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization