BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STREAMLINE MIS SPINAL FIXATION SYSTEM

    MDR report key: 19656481 · Received July 2, 2024

    Report

    Report Number
    3005031160-2024-00021
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    May 17, 2024
    Report Date
    July 2, 2024
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC.
    Product Code
    LXH
    UDI-DI
    00846468088453
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE COMPLAINANT. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER NO PHOTOGRAPHS WERE PROVIDED. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. IT WAS NOTED THAT THE SURGEON TIGHTENED THE DEVICE BEYOND THE TORQUE LIMIT. IT IS UNKNOWN IF A TORQUE LIMITING HANDLE OR HAND TIGHTENING WAS USED WHEN THE MALFUNCTION OCCURRED. A REVIEW OF MANUFACTURING RECORDS FOR THE DEVICE WAS PERFORMED AND NO DEVIATIONS WERE IDENTIFIED. THE DEVICE WAS RELEASED TO THE FIELD IN NOVEMBER 2019, RESULTING IN AN APPROXIMATE FIELD LIFE OF OVER FOUR (4) YEARS. 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. 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 TWO (2) LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE WITH POSTERIOR FIXATION USING AN MIS APPROACH. DURING THE FINAL TIGHTENING STEP IN THE PROCEDURE, IT WAS NOTED THAT THE SET SCREW MAY HAVE BEEN TIGHTENED BEYOND THE TORQUE LIMIT, CAUSING THE DISTAL TIP OF THE DRIVER TO FRACTURE OFF. NO PIECES WERE RETAINED BY THE PATIENT. A SPARE FINAL DRIVER WAS USED TO FINISH THE REMAINDER OF THE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684017 STREAMLINE MIS SPINAL FIXATION SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH XTANT MEDICAL HOLDINGS, INC. 05-FINALDRIVER2 351536 00846468088453

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male