BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 6287922 · Received January 30, 2017

    Report

    Report Number
    1000432246-2017-00003
    Event Type
    Injury
    Date Received
    January 30, 2017
    Date of Event
    July 18, 2016
    Report Date
    January 18, 2017
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    NKB
    PMA / PMN Number
    K141398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT WAS IDENTIFIED AT THE FOLLOW-UP. THE HOOK FOR CLAW AND THE COUNTER HOOK WERE ASSEMBLED BETWEEN TWO VERTEBRAE AT THE TOP OF THE CONSTRUCTION. THE UPPER VERTEBRA WHICH WAS NOT CONNECTED TO THE CONSTRUCTION COULD BE SUBMITTED TO SMALL MOVEMENTS WHICH COULD STRESS THE COUNTER HOOK AND CAUSE ITS BREAKAGE. THE COUNTER HOOK IS COMBINED WITH THE HOOK TO FORM A SELF STABLE ANCHORAGE POINT ON ONE SINGLE VERTEBRA AND NOT BETWEEN TWO VERTEBRAE. WE CONCLUDE THAT IT IS A CASE OF A CONSTRUCT BUILT NOT ACCORDING TO THE SURGICAL TECHNIQUE. THE DEVICE WAS NOT RETURNED. NOT RECEIVED.

    Description of Event or Problem · 1

    BREAKAGE OF THE LONG THORACIC COUNTER HOOK BETWEEN THE BAR AND THE LAMINAR HOOK BODY DETECTED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68626 PASS LP LONG THORACIC COUNTER HOOK NKB MEDICREA INTERNATIONAL 14B0489

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization