BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENPLACE

    MDR report key: 24710156 · Received March 30, 2026

    Report

    Report Number
    MW5186058
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 17, 2026
    Report Date
    March 24, 2026
    Manufacturer
    FEMSELECT LTD
    Product Code
    PBQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT SCHEDULED FOR SACROSPINOUS VAULT SUSPENSION AND THE SURGEON USED PELVIC LIGAMENT FIXATION SYSTEM (ENPLACE FG-0001-02 , LOT NO.23072706). THE INCLUDED SUTURE BROKE WHEN HE IS USING THE APPLICATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769812 ENPLACE FIXATION, NON-ABSORBABLE OR ABSORBABLE, FOR PELVIC USE PBQ FEMSELECT LTD ENPLACE FG-0001-02 23072706

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Other