BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STREAMLINE MIS SPINAL FIXATION SYSTEM

    MDR report key: 23209102 · Received October 3, 2025

    Report

    Report Number
    3005031160-2025-00034
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    August 26, 2025
    Report Date
    October 3, 2025
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC.
    Product Code
    HXX
    PMA / PMN Number
    K192396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION OF THE SYSTEM INSERTER SHOWED AN INSTRUMENT WITH SIGNS OF REPEATED USE AS IDENTIFIED BY MINOR SURFACE BLEMISHES. AS REPORTED, THE DISTAL TIP HAD SHEARED FROM THE SYSTEM INSERTER AND WAS NOT PRESENT. A FUNCTIONAL TEST WAS NOT COMPLETED FOR THE INSTRUMENT DUE TO THE DAMAGED CONDITION OF THE DEVICE, WHICH WAS REMOVED FROM DISTRIBUTABLE INVENTORY. A DHR REVIEW WAS PERFORMED FOR LOT # 360743 AND NO MANUFACTURING ANOMALIES WERE IDENTIFIED. THE SYSTEM INSERTER LOT MET SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. LOT # 360743 HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 05/05/2020. IT MAY BE POSSIBLE FOR THE DISTAL TIP OF THE SYSTEM INSERTER TO BREAK WHILE BEING USED IN A SURGICAL PROCEDURE IF EXCESSIVE FORCE WAS PLACED ON THE TIP. THE COMPLAINANT STATED THAT AT THE TIME OF USE, THE SYSTEM INSERTER WAS BEING USED TO INSERT A 6.5MM X 50MM SYSTEM SCREW INTO A PEDICLE THAT HAD BEEN PREPARED WITH A 5.5MM TAP. THE SYSTEM SURGICAL TECHNIQUE GUIDE SPECIFIES THAT, "TAPS ARE "TRUE TO SIZE" (NOT UNDERSIZED) AND ARE AVAILABLE IN STANDARD SIZES OF 4.5, 5.5 AND 6.5MM." IT MAY BE POSSIBLE THAT THE DISCREPANCY BETWEEN THE TAP USED AND THE SCREW BEING TOO LARGE FOR SAID PRE-TAPPED PEDICLE CONTRIBUTED TO EXCESSIVE FORCE BEING PLACED ON THE DISTAL TIP OF THE INSERTER WHILE IT WAS BEING USED TO INSERT THE PEDICLE SCREW, LEADING TO IT SHEARING FROM THE REST OF THE DEVICE. THERE HAVE BEEN NO OTHER COMPLAINTS OF SIMILAR NATURE FOR THIS INSERTER IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR FOR REPORTS OF BROKEN INSTRUMENTS AND WILL PERFORM COMPLAINT INVESTIGATIONS AS APPROPRIATE.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 09/12/2025. IT WAS REPORTED VIA EMAIL THAT A SYSTEM INSERTER WAS DAMAGED DURING A SURGICAL PROCEDURE AND WAS REQUESTED TO BE REPLACED. THE COMPLAINANT DID NOT PROVIDE PATIENT DETAILS. THE COMPLAINANT REPORTED THAT THE SYSTEM SCREW INSERTER WAS BROKEN THEY WERE INSERTING A 6.5MM X 50MM SYSTEM SCREW INTO A PRE-TAPPED PEDICLE THAT HAD BEEN TAPPED WITH A SYSTEM 5.5MM TAP. THE SURGEON SWITCHED FROM A ROUNDED HANDLE TO A T-HANDLE TO GIVE BETTER LEVERAGE. AT THE TIME, IT WAS ASSUMED THAT THE SURGEON HAD LOST CONTACT WITH THE SCREW, BUT AFTER THE ROD WAS SEATED, THEY REALIZED THAT THE TIP OF THE DRIVER HAD SHEARED OFF INTO THE SCREW HEAD. THE COMPLAINANT ALSO STATED THAT SINCE THE SCREW WAS SEATED AND THE ROD WAS INSERTED, THE DECISION WAS MADE TO LEAVE THE SHEARED TIP IN PLACE AND TO CONTINUE WITH THE REST OF THE PROCEDURE. ANOTHER SYSTEM INSERTER WAS USED TO COMPLETE THE CASE. THERE WERE NO REPORTED DELAYS OR PATIENT COMPLICATIONS. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR THE RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR INSPECTION ON 09/19/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278028 STREAMLINE MIS SPINAL FIXATION SYSTEM SCREWDRIVER HXX XTANT MEDICAL HOLDINGS, INC. 05-SIMPLEDRIVER 360743

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other