BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINVATEC SRS POPLOK

    MDR report key: 25215064 · Received May 19, 2026

    Report

    Report Number
    1017294-2026-00118
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    May 2, 2026
    Report Date
    May 19, 2026
    Manufacturer
    CONMED
    Product Code
    MBI
    PMA / PMN Number
    K091549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, GKP-2801, SUTURE ANCHOR WITH ONE #2 (5 METRIC) HI-FI SUTURE,2.8 MM, WAS USED DURING A RC REPAIR PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, ¿DURING A SURGICAL PROCEDURE ONE POPLOK SUTURE 2.8MM ANCHOR WAS FOUND DAMAGED.¿. THE DRIVER TIP FRAGMENTATION HAD FALLEN IN THE PATIENT; HOWEVER, THE FRAGMENTATION WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH AN ALTERNATE, UNKNOWN DEVICE. BOTH THE PATIENT AND DOCTOR WERE REPORTED AS ¿GOOD¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128897 LINVATEC SRS POPLOK FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI CONMED 1458177

    Patients

    Seq Age Sex Outcome Treatment
    1