BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTIS SINGLE INCISION SLING SYSTEM

    MDR report key: 24713004 · Received March 30, 2026

    Report

    Report Number
    2125050-2026-00461
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 13, 2026
    Report Date
    March 27, 2026
    Manufacturer
    COLOPLAST A/S
    Product Code
    PAH
    UDI-DI
    05708932467407
    PMA / PMN Number
    K121562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT [NC], AND CAPA. NO NC'S NOR CAPAS WERE IDENTIFIED. 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. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, QUALITY 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.

    Additional Manufacturer Narrative · 0

    AN ALTIS SLING WAS RECEIVED FOR EVALUATION. EXAMINATION OF THE SLING REVEALED THE STATIC ANCHOR ATTACHED TO THE MESH. MICROSCOPIC EXAMINATION OF THE STATIC ANCHOR REVEALED THE TINES TO BE BENT OUTWARD, INDICATING THE ANCHOR HAD BEEN IMPLANTED AND REMOVED. THE DYNAMIC SUTURE, DYNAMIC ANCHOR AND TENSIONER WERE NOT RECEIVED. MICROSCOPIC EXAMINATION OF THE DYNAMIC SUTURE APPEARED TO BE ROUGH AND IRREGULAR, INDICATING STRESS WAS EXERTED. BLOOD RESIDUE WAS NOTED ON THE MESH. THE INFORMATION RECEIVED INDICATED THE DYNAMIC SUTURE DETACHED DURING THE PROCEDURE. QUALITY CONFIRMED THE DETACHED DYNAMIC SUTURE. AS THE DYNAMIC ANCHOR AND TENSIONER WERE NOT RECEIVED, IT WAS CONCLUDED THAT THE DETACHMENT OF THE DYNAMIC SUTURE MOST LIKELY OCCURRED DURING THE TENSIONING PART OF THE PROCEDURE. DETAIL WAS NOT PROVIDED AS IF THERE WERE ANY ISSUES THAT MAY HAVE OCCURRED PRIOR TO THE DETACHMENT. AS THE DETACHMENT ENDS OF THE DYNAMIC SUTURE WERE ROUGH AND IRREGULAR, THIS INDICATED THAT EXCESS STRESS WAS MOST LIKELY EXERTED TO RESULT IN THE SEPARATION NOTED. THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT, AND CAPA. NO NCS NOR CAPAS WERE IDENTIFIED IN VEEVA. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE SUTURE ON THE DYNAMIC SIDE RIPPED FROM THE MESH WHILE INSERTING THE DYNAMIC ANCHOR. THERE WAS A SLIGHT PROCEDURE DELAY TO RETRIEVE A SECOND PRODUCT BEFORE SUCCESSFULLY COMPLETING THE CASE WITH A SECOND ALTIS. PATIENT WAS FINE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE SUTURE ON THE DYNAMIC SIDE RIPPED FROM THE MESH WHILE INSERTING THE DYNAMIC ANCHOR. THERE WAS A SLIGHT PROCEDURE DELAY TO RETRIEVE A SECOND PRODUCT BEFORE SUCCESSFULLY COMPLETING THE CASE WITH A SECOND ALTIS. PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778572 ALTIS SINGLE INCISION SLING SYSTEM FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER PAH COLOPLAST A/S 10083845_5196502400 05708932467407

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Unknown