BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTERA SPINAL FIXATION SYSTEM

    MDR report key: 19455982 · Received June 3, 2024

    Report

    Report Number
    3005031160-2024-00017
    Event Type
    Injury
    Date Received
    June 3, 2024
    Date of Event
    May 7, 2024
    Report Date
    June 3, 2024
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC.
    Product Code
    NKB
    UDI-DI
    00810076563619
    PMA / PMN Number
    K221403
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL ASSESSMENT OF THE RETURNED COMPLAINT SYSTEM IMPLANT SCREWS SHOWED BOTH PEDICLE SCREW IMPLANTS WERE FRACTURED AT AN ANGLE ON THE PROXIMAL END OF THE PEDICLE SCREW SHANK. THERE WERE ALSO TWO SYSTEM RODS RETURNED, ONE OF WHICH WAS BENT MORE THAN THE OTHER. LATERAL POST-OPERATIVE IMAGING FROM THE INDEX PROCEDURE AND POST-OPERATIVE IMAGING FROM THE REVISION PROCEDURE WERE PROVIDED BY THE COMPLAINANT FOR REVIEW AS PART OF THE COMPLAINT INVESTIGATION. A REVIEW OF THE INDEX PROCEDURE POST-OPERATIVE IMAGING WAS UNREMARKABLE. THE REVIEW IDENTIFIED A TWO-LEVEL POSTERIOR FIXATION CONSTRUCT FROM L4-S1. NO INTERBODY DEVICES WERE VISIBLE IN THE DISC SPACE. NO FURTHER ASSESSMENT COULD BE MADE USING THE IMAGE PROVIDED. POST-OPERATIVE IMAGING FROM THE REVISION PROCEDURE SHOWED TWO FRACTURED SCREWS SHANKS AT S1 AND INCLUSION OF L3 TO THE IMPLANT CONSTRUCT. DHR REVIEWS WERE PERFORMED FOR BOTH DEVICE LOTS AND THERE WERE NO MANUFACTURING ANOMALIES IDENTIFIED. BOTH DEVICE LOTS MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. PART# 150100-75050, LOT# AP22000142 HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 12/06/2022 AND PART# 150100-75055, LOT# AP22000023 HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 7/19/2022. THE SURGICAL SYSTEM IFU WARNINGS/CAUTIONS/PRECAUTIONS SECTION APPROPRIATELY STATES "RISKS IDENTIFIED WITH THE USE OF THESE DEVICES, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE DEVICE COMPONENT FAILURE, LOSS OF FIXATION/STABILIZATION, NON-UNION, VERTEBRAL FRACTURE, NEUROLOGICAL INJURY, VASCULAR OR VISCERAL INJURY.", AND "NO SPINAL IMPLANT CAN WITHSTAND BODY LOADS FOR AN INDEFINITE PERIOD OF TIME WITHOUT THE SUPPORT OF BONE. IN THE EVENT THAT SUCCESSFUL FUSION IS NOT ACHIEVED, BENDING, BREAKAGE, LOOSENING OR DISASSEMBLY OF THE DEVICE WILL OCCUR." THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE RELIABLY DETERMINED. THERE HAVE BEEN SIX OTHER COMPLAINTS OF SIMILAR NATURE FOR POST-OPERATIVE PEDICLE SCREW MALFUNCTIONS IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR REPORTS FOR POST-OPERATIVE IMPLANT MALFUNCTIONS. THIS REPORT IS ASSOCIATED WITH REPORT# 3005031160-2024-00016.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A POST-OPERATIVE VISIT DUE TO THE ONSET OF BACK PAIN AT AN ADJACENT LEVEL THAT WAS NOTED TO BE UNRELATED TO THE EXISTING POSTERIOR FIXATION CONSTRUCT, IT WAS IDENTIFIED THAT BOTH PEDICLE SCREWS AT S1 HAD BROKEN. A REVISION PROCEDURE WAS PERFORMED APPROXIMATELY ONE YEAR AFTER THE INITIAL IMPLANTATION IN WHICH THE MALFUNCTIONED SCREWS WERE REMOVED, AND THE REMAINING IMPLANT CONSTRUCT WAS EXTENDED TO L3. THE PATIENT WAS REPORTED TO BE IN GOOD HEALTH STATUS WITH NO ADDITIONAL PROCEDURES PLANNED OR REQUIRED. AN RMA# WAS ISSUED FOR RETURN OF THE EXPLANTED DEVICES, WHICH WERE RECEIVED AT THE MANUFACTURER FOR ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609640 CORTERA SPINAL FIXATION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB XTANT MEDICAL HOLDINGS, INC. 150100-75055 AP22000023 00810076563619

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization