BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFFRON ANCHOR

    MDR report key: 23156456 · Received September 26, 2025

    Report

    Report Number
    2125050-2025-01541
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    September 5, 2025
    Report Date
    September 26, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    PBQ
    PMA / PMN Number
    K220420
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 [NON-CONFORMANCES] NOR CAPAS WERE IDENTIFIED IN VEEVA. THERE WERE SEVERAL COMPLAINTS AGAINST THIS LOT IDENTIFIED WITH THE SAME FAILURE MODE. A SUPPLIER INVESTIGATION INTO THIS LOT WILL BE EXECUTED AND FURTHER DETAILS COMMENTED IN THE FINAL ANSWER. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, COLOPLAST CANNOT COMMENT ON THE CONDITION OF THE DEVICE. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE, THE VAGINAL VAULT KEPT FALLING INDICATING THAT EITHER THE ANCHORS, SUTURE, OR TISSUE FAILED TO HOLD. THE FAILURE WAS IDENTIFIED DURING SUTURE TIE-DOWN. THE ANCHORS WERE NOT FOUND. IT WAS NOTED THE DOCTOR USED THE PULLEY METHOD WHICH MAY HAVE CONTRIBUTED TO THE FAILURE. A TOTAL OF 6 ANCHORS WERE PLACED, 4 ANCHORS FAILED AND 2 ANCHORS WERE SUCCESSFUL. THERE WAS A DIFFERENT TOOL EACH TIME BECAUSE THE SURGERY BROKE DOWN/CLEANED UP AND THEN HAD TO RE-SET AFTER THE FAILURE WAS VISUAL BEFORE THE PATIENT WAS AWAKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310521 SAFFRON ANCHOR SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE PBQ COLOPLAST A/S 9066459_5203501400

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other