BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STREAMLINE MIS SPINAL FIXATION SYSTEM

    MDR report key: 23761790 · Received December 9, 2025

    Report

    Report Number
    3005031160-2025-00042
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 4, 2025
    Report Date
    December 9, 2025
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC.
    Product Code
    NKB
    UDI-DI
    00191083019598
    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 WORN LASER MARKINGS AND SURFACE SCRATCHES. THE DISTAL TIP OF THE INSTRUMENT WAS FRACTURED AS REPORTED, AND THE BROKEN PORTION WAS NOT RETURNED. THE COMPLAINT SOURCE CONFIRMED THE BROKEN PORTION OF THE DRIVER WAS RETURNED WITH THE BROKEN DRIVER AND PARTIAL IMPLANT CONSTRUCT. A VISUAL ASSESSMENT OF THE PARTIAL IMPLANT CONSTRUCT SHOWED THE SCREW IMPLANT SHANK WAS SEPARATED AS REPORTED. THE TULIP HEAD HAD A SYSTEM ROD ENGAGED WITH A LOCKED CAP. THE RETENTION COLLAR OF THE SYSTEM SCREW IMPLANT APPEARED DAMAGED. A DHR REVIEW WAS PERFORMED FOR THE SYSTEM SCREWDRIVER LOT AND THERE WAS NO MANUFACTURING ANOMALIES IDENTIFIED. THE INSTRUMENT LOT MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THE INSTRUMENT LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 5/17/2017. A DHR REVIEW WAS PERFORMED FOR THE SYSTEM IMPLANT SCREW AND THERE WAS NO MANUFACTURING ANOMALIES IDENTIFIED. THE IMPLANT LOT MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THE IMPLANT LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 8/14/2024. THE SYSTEM SURGICAL TECHNIQUE GUIDE PROVIDES GUIDANCE ON APPROPRIATE USE OF THE SYSTEM. SECTION 12: FINAL SET SCREW LOCKING INCLUDES A CAUTIONARY STATEMENT THAT INCLUDES, "EXCESSIVE LEVERAGE FORCES MAY INCREASE THE RISK FOR PREMATURE EXTENSION BREAKAGE, TULIP HEAD DISSOCIATION, SCREW FRACTURE, PEDICLE FRACTURE AND/OR SCREW PULLOUT". THE ROOT CAUSE OF THE BROKEN SCREWDRIVER IS EXCESSIVE OR ABNORMAL FORCE APPLIED TO THE SCREWDRIVER, WHICH COULD RESULT IN THE OBSERVED INSTRUMENT MALFUNCTION. THE ROOT CAUSE OF THE SYSTEM SCREW IMPLANT MALFUNCTION COULD NOT BE RELIABLY DETERMINED. THERE HAVE BEEN TWO OTHER COMPLAINTS OF SIMILAR NATURE FOR THE SYSTEM SCREWDRIVER, AND ONE OTHER COMPLAINT OF SIMILAR NATURE FOR THE SCREW IMPLANT IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR FOR REPORTS OF PRODUCT COMPLAINTS AND PERFORM COMPLAINT INVESTIGATIONS AND ASSOCIATED REGULATORY REPORTING AS APPROPRIATE.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 11/10/2025. IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE ON (B)(6) 2025 A SYSTEM POLYAXIAL SCREW HAD A MALFUNCTION IN WHICH THE IMPLANT SCREW SHANK SEPARATED FROM THE TULIP HEAD OF THE IMPLANT. THE IMPLANT SCREW ALREADY HAD THE ASSOCIATED ROD PLACED AND LOCKED INTO THE SCREW WHEN THE MALFUNCTION OCCURRED. IN AN ATTEMPT TO UTILIZE THE ROD, THE SURGEON ATTEMPTED TO LOOSEN THE REMOVED IMPLANT CONSTRUCT. DURING THE DISASSEMBLY OF THE IMPLANT CONSTRUCT OUTSIDE OF THE SURGICAL SITE THE DISTAL TIP OF A SYSTEM SCREWDRIVER WAS BROKEN. THE SHANK OF THE BROKEN SCREW WAS REMOVED, AND THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED BY IMPLANTING AN ALTERNATE AVAILABLE IMPLANT WITHOUT KNOWN COMPLICATIONS. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT AND IMPLANT, WHICH WERE RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 11/11/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2720945 STREAMLINE MIS SPINAL FIXATION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB XTANT MEDICAL HOLDINGS, INC. 05-PA-65-45 465558 00191083019598

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown