BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND HEAD INTERFERENCE SCREW LIGAFIX 60 Ø 10 MM - LG 35 MM

    MDR report key: 8603061 · Received May 13, 2019

    Report

    Report Number
    3004549189-2019-00072
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    May 4, 2015
    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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. THIS BATCH OF SCREWS PRESENTS NO MANUFACTURING DEFECT. EVERYTHING CONFORMS TO SPECIFICATIONS. IN THE ABSENCE OF ADDITIONAL INFORMATION AND IN THE IMPOSSIBILITY OF RECOVERING THE SCREW FOR EXPERTISE, THE CAUSE OF THE EVENT IS NOT DETERMINABLE.

    Description of Event or Problem · 1

    FNC (B)(4) - FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. COMPLAINT RECEIVED FROM THE CLINIC REGARDING SCREW WHICH WAS SAID TO BE « DEFECTIVE, DESIGN FAILURE » WHICH WAS "IMPLANTED AND THEN EXPLANTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396614 ROUND HEAD INTERFERENCE SCREW LIGAFIX 60 Ø 10 MM - LG 35 MM INTERFERENCE SCREW MAI S.B.M. SAS 140468

    Patients

    Seq Age Sex Outcome Treatment
    1 Other