BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STREAMLINE OCT

    MDR report key: 23697962 · Received December 2, 2025

    Report

    Report Number
    3005031160-2025-00046
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 2, 2025
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC.
    Product Code
    HWN
    UDI-DI
    00840311237876
    PMA / PMN Number
    K172139
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL ASSESSMENT OF THE DEVICE SHOWED IN INSTRUMENT WITH REPEATED USE AS IDENTIFIED BY MINOR SURFACE BLEMISHES AND WORN BUT LEGIBLE LASER MARKINGS. THE DISTAL LEFT ARM OF THE SMALL DISTRACTOR HAD BEEN FRACTURED FROM THE DEVICE, AND THE RETAINING PIN HAD FALLEN OUT OF THE SPACE IT ONCE IN WAS DUE TO THE FRACTURE. THE DISTAL RIGHT DISTRACTION ARM REMAINED INTACT WITH THE PIN IN PLACE. 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#: 360802, AND NO MANUFACTURING ANOMALIES WERE IDENTIFIED. THE SYSTEM DISTRACTOR LOT MET SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. LOT#: 360802 HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 02/20/2020. THE ROOT CAUSE OF THIS COMPLAINT IS EXPOSURE TO EXTREME FORCES. THE SYSTEM DISTRACTOR IS ROUTINELY SUBJECTED TO EXTREME FORCES AND STERILIZATION CYCLES. EXTREME FORCES EXPERIENCED DURING USE AND EXTREME TEMPERATURE FLUCTUATIONS FROM THE STERILIZATION PROCESS COULD POSSIBLY LEAD TO THE DEGRADATION OF THE MATERIALS USED IN THE CONSTRUCTION OF THE DEVICE OVER TIME, LEADING TO AN EVENTUAL FRACTURE. THERE HAVE BEEN NO OTHER COMPLAINTS OF SIMILAR NATURE IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR THE FIELD FOR SYSTEM DISTRACTORS THAT ARE REPORTED AS BROKEN/WORN OUT AND WILL PERFORM COMPLAINT INVESTIGATIONS AS APPROPRIATE.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 11/05/2025. THE COMPLAINANT REPORTED THAT A SYSTEM DISTRACTOR HAD BROKEN WHILE BEING USED IN A POSTERIOR CERVICAL SURGERY. THE COMPLAINANT STATED THAT, "WHEN PUT UNDER LOAD, THE HINGED JOINT CAN BECOME A FAILURE POINT. IT WAS BEING USED AS INTENDED, ON THE ROD, B/W TWO SCREWS." A MORE ROBUST DISTRACTOR FROM A DIFFERENT SYSTEM WAS USED TO COMPLETE THE SURGERY. THERE WERE NOT REPORTED PATIENT COMPLICATIONS OR DELAYS AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2810778 STREAMLINE OCT DISTRACTOR HWN XTANT MEDICAL HOLDINGS, INC. 26-DISTRACTOR-SM 00840311237876

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other