BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULLUP® FOR CORTICAL TUNNEL Ø 4.5 MM

    MDR report key: 8639446 · Received May 24, 2019

    Report

    Report Number
    3004549189-2019-00089
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    December 15, 2015
    Report Date
    May 24, 2019
    Manufacturer
    S.B.M. SAS
    Product Code
    MBI
    PMA / PMN Number
    K151004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. EVENT OCCURED IN (B)(6). NO RECOVERY OF THE DEVICE FOR EXPERTISE. CORRECTIVE ACTIONS IMPLEMENTED TO SOLVE THIS PROBLEM: REINFORCEMENT OF THE CONTROL METHOD: USE OF AN ANGLED ASSEMBLY (45°) FOR PERFORMANCE QUALIFICATION. IMPLEMENTATION OF POST-POLISHING ASPECT CONTROL: NO SCRATCHES OR UNEVENNESS WITH A BINOCULAR.

    Description of Event or Problem · 1

    FNC (B)(4) - FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. ACCORDING TO THE DISTRIBUTOR, BREAKING OF THE BRAID DURING THE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433473 PULLUP® FOR CORTICAL TUNNEL Ø 4.5 MM ADJUSTABLE FIXATION SYSTEM FOR LIGAMENT RECONSTRUCTION MBI S.B.M. SAS 152999

    Patients

    Seq Age Sex Outcome Treatment
    1 Other