BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.U.S.T. PEDICLE SCREW SYSTEM

    MDR report key: 4351106 · Received November 7, 2014

    Report

    Report Number
    3005180920-2014-00145
    Event Type
    Injury
    Date Received
    November 7, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    PMA / PMN Number
    K121115
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: MUST PEDICLE SCREW 6-45MM: REF. 03.50.018 . LOT 122698 ((B)(4) DEVICES PRODUCED): NO ANOMALIES HAVE BEEN FOUND RELATED TO THE PROBLEM OCCURRED. ALL THE ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REVENT REPORTED. THE BREAKAGE OF PEDICLE SCREWS IS A KNOWN COMPLICATION IN CASE OF DELAYED FUSION OR AN INSTABLE SEGMENT.

    Description of Event or Problem · 1

    IMP REF# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718673 M.U.S.T. PEDICLE SCREW SYSTEM PEDICLE SCREW 6 X 45 MM KWP MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1