BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STREAMLINE MIS SPINAL FIXATION SYSTEM

    MDR report key: 19660615 · Received July 2, 2024

    Report

    Report Number
    3005031160-2024-00020
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 3, 2024
    Report Date
    July 2, 2024
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC.
    Product Code
    LXH
    UDI-DI
    00846468050658
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FINAL DRIVER WAS RETURNED TO XTANT FOR EVALUATION AND THE EVENT WAS CONFIRMED AS VISUAL EVALUATION OF THE DRIVER IDENTIFIED A FRACTURED AND MISSING DISTAL TIP COMPONENT. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A REVIEW OF MANUFACTURING RECORDS FOR THE DEVICE WAS PERFORMED AND NO DEVIATIONS WERE IDENTIFIED. THE DEVICE WAS RELEASED TO THE FIELD IN MAY 2017, RESULTING IN AN APPROXIMATE FIELD LIFE OF SEVEN (7) YEARS. THE COMPLAINT DEVICE AND ASSOCIATED TORQUE HANDLE ARE SCHEDULED TO BE SHIPPED TO THE MANUFACTURING VENDOR FOR FURTHER TESTING. NO FURTHER INVESTIGATION WAS ABLE TO BE COMPLETED AT THIS TIME. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION PROVIDED; HOWEVER, MAY HAVE BEEN RELATED TO EXCESSIVE FORCE APPLIED TO THE INSTRUMENT AND/OR WEAR OR OTHER DAMAGE TO THE INSTRUMENT OVER TIME. IT IS UNKNOWN HOW MANY USES THE INSTRUMENT HAS UNDERGONE AFTER RELEASE TO THE FIELD. THE IFU FOR THE STREAMLINE MIS SYSTEM WARNS "INSTRUMENTS ARE SUBJECT TO DAMAGE DURING USE AS WELL AS LONG-TERM POTENTIALLY DAMAGING EFFECTS SUCH AS WEAR. DAMAGE MAY RESULT IN SIGNIFICANT RISKS TO SAFETY AND/OR INABILITY TO FUNCTION AS INTENDED. IF INSTRUMENTS ARE DAMAGED OR BROKEN DURING USE, METAL FRAGMENTS CAN BE VIEWED BY RADIOGRAPHIC ASSESSMENT. IT IS THE SURGEON'S RESPONSIBILITY TO CAREFULLY CONSIDER THE RISKS AND BENEFITS OF RETRIEVING THE FRAGMENTS". ADDITIONALLY, THE IFU INSTRUCTS THE USER "PRIOR TO AND DURING USE, INCLUDING REPROCESSING, INSPECT INSTRUMENTS FOR: DAMAGE SUCH AS BUT NOT LIMITED TO, WEAR, DISCOLORATION, CORROSION, CRACKING, FRACTURE, OR UNRECOGNIZABLE MARKINGS. PROPER FUNCTION INCLUDING BUT NOT LIMITED TO, SHARPNESS, MOVEMENT OF HINGES AND COUPLINGS, JOINT STABILITY, AND LEGIBLE MARKINGS. INSTRUMENTS THAT SHOW SIGNS OF DAMAGE OR AN INABILITY TO FUNCTION SHOULD NOT BE USED AND SHOULD BE RETURNED TO THE MANUFACTURER". IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL THORACOLUMBAR POSTERIOR FIXATION PROCEDURE USING AN MIS APPROACH. DURING THE FINAL TIGHTENING STEP IN THE PROCEDURE, THE DISTAL TIP OF THE FINAL DRIVER FRACTURED OFF AND BECAME STUCK WITHIN THE MATING FEATURE OF THE SET SCREW. THE SURGEON UTILIZED A BURR TO REMOVE THE FRACTURED PIECE, RESULTING IN APPROXIMATELY A 2 HOUR SURGICAL DELAY. THE SET SCREW WAS REMOVED AND REPLACED WITH A NEW DEVICE AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821565 STREAMLINE MIS SPINAL FIXATION SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH XTANT MEDICAL HOLDINGS, INC. 05-FINALDRIVER 280838 00846468050658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 02-TL-HANDLE, LN 220968