BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS MIS

    MDR report key: 5438401 · Received February 16, 2016

    Report

    Report Number
    1000432246-2016-00001
    Event Type
    Injury
    Date Received
    February 16, 2016
    Date of Event
    January 12, 2016
    Report Date
    February 15, 2016
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    K112493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE THREADED EXTENSION WAS DETACHED FROM THE SCREW HEAD. THE SCREW HEAD IS DISTORTED ON ONE SIDE. THIS TYPE OF FAILURE IS PROBABLY DUE TO A HIGH BENDING STRESS APPLIED ON THE THREADED EXTENSION DURING THE TIGHTENING OF THE NUT. NORMALLY, THE CRIMPING OF THE SCREW HEAD HAS TO RESIST TO A BENDING STRESS MUCH HIGHER THAN THE STRESS NEEDED TO TIGHTEN THE NUT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. THE RESULTS OF THE TESTS PERFORMED ON THE DEVICE DURING ITS MANUFACTURING COMPLY WITH THE REQUIREMENTS. WE CONSIDER THIS TO BE AN ISOLATED CRIMPING DEFECT BECAUSE ONLY THIS CASE OF BREAKAGE WAS REPORTED FROM 2012.

    Description of Event or Problem · 1

    THE THREADED EXTENSION HAD DETACHED FROM THE SCREW DURING THE INITIAL SURGERY. THE SURGEON HAD DETECTED THIS BREAKAGE BUT HAD DECIDED TO LEAVE THE SCREW AND INCREASE ITS CONSTRUCTION WITH AN ADDITIONAL LEVEL. THE BROKEN SCREW WAS REMOVED DURING THE ABLATION OF SYSTEM 6 MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96730 PASS MIS POSTERIOR PEDICLE SCREW SYSTEM MNI MEDICREA INTERNATIONAL Ø6.5 MM X 40 MM 12I0178

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization