BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND HEAD INTERFERENCE SCREW LIGAFIX 60 Ø 7 MM - LG 25 MM

    MDR report key: 8603062 · Received May 13, 2019

    Report

    Report Number
    3004549189-2019-00070
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Report Date
    April 2, 2019
    Manufacturer
    S.B.M. SAS
    Product Code
    MAI
    PMA / PMN Number
    K122228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. MANUFACTURING DATA CONFORMS TO SPECIFICATIONS : THE SCREW CAN NOT BE THE CAUSE OF THE REPORTED INCIDENT. NO POSSIBILITY TO ASSESS THE SCREW. NO RECURRENCE. THE CAUSE OF THE BREAKAGE OF THE THREAD COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    FNC (B)(4) - FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. "THE GRAFT WAS NOT SECURED, THE THREAD BROKE AND THE SURGEON HAD TO START EVERYTHING OVER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396403 ROUND HEAD INTERFERENCE SCREW LIGAFIX 60 Ø 7 MM - LG 25 MM INTERFERENCE SCREW MAI S.B.M. SAS 142119

    Patients

    Seq Age Sex Outcome Treatment
    1 Other