BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULLUP DEVICE PULLUP®XL FOR CORTICAL TUNNEL Ø5 TO 10 MM

    MDR report key: 8657173 · Received May 31, 2019

    Report

    Report Number
    3004549189-2019-00100
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. EXPERTISE RESULT : THE BREAK OF THE PULLUP BRAID COMES FROM THE PROMINENCE OF EDGES AT THE JUNCTION OF R0.3 WITH Ø1.6 HOLES. CORRECTIVE ACTIONS : CHANGE IN THE FINISH OF THE PADS TO COMPLETELY ELIMINATE THIS DEFECT: REINFORCEMENT OF MICROBILLAGE - ADDITION OF A CORUNDUM ACTION.

    Description of Event or Problem · 1

    FNC (B)(4) - FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. BROKEN BRAID. " THE RUPTURE OF THE PULLUP XL SYSTEM OCCURRED DURING THE RECONSTRUCTION CONTROL STEP: "CYCLING"."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450775 PULLUP DEVICE PULLUP®XL FOR CORTICAL TUNNEL Ø5 TO 10 MM ADJUSTABLE FIXATION SYSTEM FOR LIGAMENT RECONSTRUCTION MBI S.B.M. SAS 170435

    Patients

    Seq Age Sex Outcome Treatment
    1 Other