BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND HEAD INTERFERENCE SCREW LIGAFIX 30 Ø 9 MM - LG 30 MM

    MDR report key: 8598530 · Received May 10, 2019

    Report

    Report Number
    3004549189-2019-00049
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    November 20, 2015
    Report Date
    March 28, 2019
    Manufacturer
    S.B.M. SAS
    Product Code
    MAI
    PMA / PMN Number
    K122228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    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. IN THE ABSENCE OF ADDITIONAL INFORMATION AND IN THE IMPOSSIBILITY OF RECOVERING THE SCREW FOR EXPERTISE, THE CAUSE OF THESE BREAKAGE IS NOT DETERMINABLE.

    Description of Event or Problem · 1

    FNC (B)(4) - FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. 2 SCREWS BROKE DURING SURGERY. A THIRD SCREW WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393216 ROUND HEAD INTERFERENCE SCREW LIGAFIX 30 Ø 9 MM - LG 30 MM INTERFERENCE SCREW MAI S.B.M. SAS 143951

    Patients

    Seq Age Sex Outcome Treatment
    1 Other