BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFFRON ANCHOR

    MDR report key: 19857199 · Received July 29, 2024

    Report

    Report Number
    2125050-2024-01153
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    July 3, 2024
    Report Date
    July 29, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    PBQ
    PMA / PMN Number
    K220420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT, AND CAPA. NO NCS NOR CAPAS WERE IDENTIFIED IN VEEVA. THERE WERE SEVERAL COMPLAINTS AGAINST THIS LOT IDENTIFIED WITH THE SAME FAILURE MODE. AN INVESTIGATION INTO THIS LOT WILL BE EXECUTED BY THE SUPPLIER AND FURTHER DETAILS COMMENTED AT A LATER DATE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, DURING TIE DOWN, THE ANCHOR PULLED OUT. THERE WAS SOME TISSUE IN THE ANCHORS AND THE ANCHOR BARBS SEEMED A LITTLE DISTORTED ON PULL OUT. IT WAS NOTED THE DOCTOR IS A LONGTIME CAPIO USER AND IS THEREFORE USED TO A STRONG SUTURE HOLD AND STRUGGLED WITH THE PULLOUT OF THE ANCHOR WHEN TYING DOWN TO THE LIGAMENT. THE PROCEDURE WAS EVENTUALLY COMPLETED WITH A SUCCESSFUL SAFFRON ANCHOR PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281808 SAFFRON ANCHOR SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE PBQ COLOPLAST A/S 8868311_5203501400

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Unknown