BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STREAMLINE MIS SPINAL FIXATION SYSTEM

    MDR report key: 22534945 · Received July 17, 2025

    Report

    Report Number
    3005031160-2025-00023
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    June 18, 2025
    Report Date
    July 17, 2025
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC
    Product Code
    NKB
    UDI-DI
    00846468050658
    PMA / PMN Number
    K192396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL ASSESSMENT OF THE RETURNED SYSTEM SCREWDRIVER SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY SURFACE SCRATCHES AND WORN LASER MARKING. THE DISTAL TIP OF THE INSTRUMENT WAS FRACTURED AND NOT PRESENT AS REPORTED. A FUNCTIONALITY ASSESSMENT WAS NOT PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED DRIVER, WHICH WAS REMOVED FROM DISTRIBUTABLE INVENTORY. A DHR REVIEW WAS PERFORMED FOR THE LOT AND THERE WAS NO MANUFACTURING ANOMALIES IDENTIFIED. THE INSTRUMENT LOT MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 06/03/2020. THE TORQUE LIMITING HANDLE THAT WAS CONNECTED TO THE DRIVER WHEN THE MALFUNCTION OCCURRED WAS RETURNED WITH THE DRIVER. AFTER ASSESSMENT AND TESTING OF THE TORQUE LIMITING HANDLE, IT WAS FOUND TO BE NOT LIMITING TORQUE AS INTENDED (SHOULD LIMIT APPLIED TORQUE AT 80 IN/BS, AND CONSISTENTLY TESTED OVER THE LIMIT AT 107, 124, 120, 117 IN/LB). THE ROOT CAUSE OF THE BROKEN DISTAL TIP WAS DETERMINED TO BE EXCESSIVE ROTATIONAL FORCE DUE TO UTILIZATION OF THE OUT OF CALIBRATION TORQUE LIMITING HANDLE. IT MAY ALSO BE POSSIBLE FOR THE DISTAL TIP OF THE SCREWDRIVER TO BE BROKEN IF THE SCREWDRIVER WAS SHIFTED OUT OF ALIGNMENT WHILE ENGAGED WITH A SYSTEM IMPLANT SCREW. THERE HAVE BEEN TWO OTHER COMPLAINTS OF SIMILAR NATURE IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR FOR REPORTS OF MALFUNCTIONED SYSTEM INSTRUMENTS AND PERFORM COMPLAINT INVESTIGATIONS AS APPROPRIATE.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2025. IT WAS REPORTED THAT FINAL TIGHTENING A SYSTEM SCREW DURING A LUMBAR FUSION PROCEDURE, THE DISTAL TIP OF A SYSTEM SCREWDRIVER WAS BROKEN AND REQUESTED TO BE REPLACED. THERE WAS A MINIMAL DELAY IN TREATMENT AND NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR THE RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615398 STREAMLINE MIS SPINAL FIXATION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB XTANT MEDICAL HOLDINGS, INC 05-FINALDRIVER 364246 00846468050658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown