BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTILINK-TS IBF SYSTEM

    MDR report key: 23722092 · Received December 4, 2025

    Report

    Report Number
    3005031160-2025-00040
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    October 30, 2025
    Report Date
    December 4, 2025
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC.
    Product Code
    MAX
    PMA / PMN Number
    K213493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL AND FUNCTIONAL ASSESSMENTS WERE UNABLE TO BE PERFORMED DUE TO THE IMPLANT REMAINING IN THE PATIENT. X-RAY IMAGES WERE PROVIDED WHICH CONFIRMS THE PLACEMENT OF THE IMPLANT. NO ADDITIONAL DETAILS WERE PROVIDED BY THE COMPLAINANT REGARDING THE IMPLANT. A DHR REVIEW WAS PERFORMED FOR LOT#: 462013 AND NO MANUFACTURING ANOMALIES WERE IDENTIFIED. THE IMPLANT LOT MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 04/26/2024. THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED; HOWEVER, IT MAY BE DUE TO THE INSERTER NOT DISENGAGING IF THERE WAS NOT ENOUGH SPACE DUE TO PATIENT ANATOMY. THERE HAVE NOT BEEN COMPLAINTS OF A SIMILAR NATURE IN THE PAST TWELVE MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR FOR REPORTS OF FRACTURED IMPLANTS AND PERFORM COMPLAINT INVESTIGATIONS AS APPROPRIATE.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 11/05/2025. IT WAS REPORTED THAT DURING A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE PERFORMED ON (B)(6) 2025, AN INSERTER WOULD NOT DISENGAGE FROM AN IMPLANT, RESULTING IN A PIECE FRACTURING OFF THE IMPLANT. THE IMPLANT WAS UNABLE TO BE RETRIEVED AND REMAINS IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS OR DELAY IN SURGERY ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2448083 FORTILINK-TS IBF SYSTEM INTERVERTEBRAL BODY FUSION DEVICE MAX XTANT MEDICAL HOLDINGS, INC. 65-TS-8-26-6L 462013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown