BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTIS SINGLE INCISION SLING SYSTEM

    MDR report key: 22460107 · Received July 9, 2025

    Report

    Report Number
    2125050-2025-01115
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    June 13, 2025
    Report Date
    October 23, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    PAH
    UDI-DI
    05708932467407
    PMA / PMN Number
    K121562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA.¿THERE WERE NO NONCONFORMING REPORTS CONFIRMED IN VEEVA TO BE ASSOCIATED. A PREVENTATIVE CAPA HAS BEEN HISTORICALLY OPENED FOR THE ALTIS PRODUCT LINE TO INVESTIGATE INCREASED RATES OF MESH TO SUTURE OR ANCHOR TO SUTURE BOND FAILURES WHICH IS BEING REPORTED IN THIS COMPLAINT. THERE WERE SEVERAL COMPLAINTS IDENTIFIED AGAINST THIS LOT; HOWEVER, WITH VARIOUS FAILURE MODES. THEREFORE, THIS IS NOT CONSIDERED A TREND. DEVICES MET SPECIFICATION PRIOR TO RELEASE.

    Additional Manufacturer Narrative · 0

    AN ALTIS SLING WAS RECEIVED FOR EVALUATION. EXAMINATION OF THE RETURNED SLING REVEALED THE TENSIONER WAS NEAR THE LOOP OF THE DYNAMIC SUTURE, AND THE DYNAMIC AND STATIC SUTURES WERE STILL ATTACHED TO THE MESH. THE DYNAMIC ANCHOR WAS MISSING FROM THE TENSIONER, AND WAS NOT RECEIVED. BLOOD RESIDUE WAS NOTED ON THE SLING. THE INFORMATION RECEIVED INDICATED THE DYNAMIC ANCHOR BROKE OFF THE SUTURE DURING TENSIONING. QUALITY CONFIRMED THE DYNAMIC ANCHOR HAD DETACHED FROM THE TENSIONER. BASED ON THE IMPLANT PROCESS, IF PROPERLY PLACED, THE DYNAMIC SUTURE WOULD HAVE BEEN ADJUSTED AFTER THE DYNAMIC ANCHOR WAS PLACED. THE TENSIONING PROCESS WOULD MOST LIKELY HAVE RESULTED IN THE TENSIONER BEING NEARER TO THE MESH THAN THE DYNAMIC SUTURE LOOP (AS NOTED ON THE RETURNED PRODUCT). THE DYNAMIC ANCHOR MAY HAVE DETACHED FROM THE TENSIONER, BUT IF PROPERLY PLACED, THE DYNAMIC ANCHOR WOULD HAVE MOST LIKELY REMAINED INSIDE THE PATIENT. THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NONCONFORMING REPORTS CONFIRMED IN VEEVA TO BE ASSOCIATED. DEVICES MET SPECIFICATION PRIOR TO RELEASE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR BROKE AT THE DYNAMIC END WHILE TENSIONING. A SECOND SLING WAS USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE ANCHOR BROKE AT THE DYNAMIC END WHILE TENSIONING. A SECOND SLING WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162304 ALTIS SINGLE INCISION SLING SYSTEM FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER PAH COLOPLAST A/S 9937882_5196502400 05708932467407

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown