BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 4240024 · Received November 10, 2014

    Report

    Report Number
    1000432246-2014-00004
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    July 16, 2014
    Report Date
    October 23, 2014
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    K123138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE THREADED EXTENSION WAS DETACHED FROM THE SCREW HEAD. THE SCREW HEAD IS DISTORTED ON ONE SIDE AND THE THREADED EXTENSION HEAD IS DAMAGED ON TWO SIDE OF THE HEXAGON. THIS TYPE OF FAILURE IS PROBABLY DUE TO A BENDING STRESS APPLIED ON THE THREADED EXTENSION DURING THE TIGHTENING OF THE NUT. NORMALLY, THE CRIMPING OF THE SCREW HEAD RESISTS A BENDING STRESS MUCH HIGHER THAN THE STRESS NEEDED TO TIGHTEN THE NUT. IN THIS CASE, THE CRIMPING OF THE SCREW HEAD DIDN'T WITHSTAND THE BENDING STRESSES APPLIED DURING THE FINAL TIGHTENING OF 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. (B)(4).

    Description of Event or Problem · 1

    WHEN PERFORMING THE FINAL NUT TIGHTENING ON A PEDICLE SCREW, THE THREADED EXTENSION DETACHED FROM THE SCREW HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723315 PASS LP POSTERIOR PEDICLE SCREW SYSTEM MNI MEDICREA INTERNATIONAL Ø6.5 MM X 35 MM 13L0224

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization