BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STREAMLINE MIS SPINAL FIXATION SYSTEM

    MDR report key: 20919979 · Received December 12, 2024

    Report

    Report Number
    3005031160-2024-00040
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 14, 2024
    Report Date
    December 12, 2024
    Manufacturer
    XTANT MEDICAL, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. THE ASSOCIATED TORQUE HANDLE WAS REQUESTED TO BE SHIPPED TO THE MANUFACTURING VENDOR FOR FURTHER TESTING BUT HAS NOT BEEN RECEIVED AT THIS TIME. A REVIEW OF THE DHR SHOWED THAT THE DEVICE MET SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THE DEVICE WAS RELEASED TO THE FIELD IN OCTOBER OF 2020 RESULTING IN AN APPROXIMATE SHELF LIFE OF 4 YEARS AND 2 MONTHS. 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, IT 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 LUMBAR FUSION PROCEDURE. DURING TIGHTENING OF ONE OF THE SCREWS, THE TIP OF THE FINAL DRIVER FRACTURED OFF. IT WAS REPORTED THAT THERE WERE MINIMAL DELAYS IN SURGERY AND THAT THE SURGERY WAS COMPLETED WITH NO ADVERSE EFFECT ON THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2416307 STREAMLINE MIS SPINAL FIXATION SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH XTANT MEDICAL, INC. 05-FINALDRIVER 380899

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention