BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOSITPC 30 8X25MM

    MDR report key: 8502641 · Received April 11, 2019

    Report

    Report Number
    3004549189-2019-00017
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    October 22, 2015
    Report Date
    March 19, 2019
    Manufacturer
    S.B.M. SAS
    Product Code
    MAI
    PMA / PMN Number
    K122228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. THIS BATCH OF SCREWS PRESENTS NO MANUFACTURING DEFECT. EVERYTHING CONFORMS TO SPECIFICATIONS. NO RETURN OF THE DAMAGED SCREW (DISCARDED BY THE NURSE): NO EXPERTISE POSSIBLE. ORIGIN OF THE BREAK IS UNIDENTIFIABLE.

    Description of Event or Problem · 1

    FNC (B)(4) - FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. "THE SCREW FRACTURED UPON INSERTION. ANOTHER SCREW WAS USED TO COMPLETE THE PROCEDURE. THIS CAUSED A DELAY OF 31 TO 60 MINUTES IN THE PROCEDURE. THE SCREW IS NOT AVAILABLE FOR RETURN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298541 COMPOSITPC 30 8X25MM INTERFERENCE SCREW MAI S.B.M. SAS 151300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other