BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULLUP® FOR CORTICAL TUNNEL Ø 4.5 MM

    MDR report key: 8657178 · Received May 31, 2019

    Report

    Report Number
    3004549189-2019-00096
    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
    PE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST . EVENT OCCURED IN (B)(6). IN THE ABSENCE OF RECOVERY OF THE DM, THE ORIGIN OF THE BREAKAGE IS NOT CLEARLY IDENTIFIABLE. THE PRODUCT HAS BEEN REWORKED TO IMPROVE MANUFACTURING REPRODUCIBILITY AND RELIABILITY.

    Description of Event or Problem · 1

    FNC (B)(4) - FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. WHITE SUTURE BROKE DURING SURGERY / ACL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450772 PULLUP® FOR CORTICAL TUNNEL Ø 4.5 MM ADJUSTABLE FIXATION SYSTEM FOR LIGAMENT RECONSTRUCTION MBI S.B.M. SAS 153557

    Patients

    Seq Age Sex Outcome Treatment
    1 Other