BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULLUP® FOR CORTICAL TUNNEL Ø 4.5 MM

    MDR report key: 8657172 · Received May 31, 2019

    Report

    Report Number
    3004549189-2019-00093
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Report Date
    May 31, 2019
    Manufacturer
    S.B.M. SAS
    Product Code
    MBI
    PMA / PMN Number
    K151004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. EVENT OCCURED IN (B)(6). NO POSSIBLE RECOVERY OF THE DEVICE. NOT ENOUGH INFORMATION IN OUR POSSESSION ALLOWING US TO IDENTIFY THE ORIGIN OF THIS BREAKAGE.

    Description of Event or Problem · 1

    FNC (B)(4) - FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. PULLUP BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450769 PULLUP® FOR CORTICAL TUNNEL Ø 4.5 MM ADJUSTABLE FIXATION SYSTEM FOR LIGAMENT RECONSTRUCTION MBI S.B.M. SAS 160258

    Patients

    Seq Age Sex Outcome Treatment
    1 Other