BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO

    MDR report key: 12057129 · Received June 24, 2021

    Report

    Report Number
    12057129
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 10, 2021
    Report Date
    June 21, 2021
    Manufacturer
    CAYENNE MEDICAL, INC.
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ZIMMER BIOMET QUATTRO LINK KNOTLESS ANCHOR 2.9MM (CM-9129, LOT #: 77384-2, EXPIRATION DATE: 08/27/2025) WAS FOUND TO BE A FAULTY ANCHOR. THE QUATTRO LINK KNOTLESS ANCHOR 2.9 MM WAS SENT TO CLINICAL ENGINEERING FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955288 QUATTRO FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI CAYENNE MEDICAL, INC. CM-9129 77384-2

    Patients

    Seq Age Sex Outcome Treatment
    1