BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COFLEX INTERLAMINAR TECHNOLOGY

    MDR report key: 20966398 · Received December 18, 2024

    Report

    Report Number
    3005031160-2024-00047
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    July 1, 2024
    Report Date
    December 18, 2024
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC
    Product Code
    NQO
    PMA / PMN Number
    P110008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REMAINS IN THE PATIENT, SO THE DEVICE WAS UNABLE TO BE ASSESSED. MRI AND LUMBAR X-RAYS HAVE NOT PROVIDED TO THE MANUFACTURING FACILITY. A DHR REVIEW WAS PERFORMED FOR THE COMPLAINT DEVICE LOT, AND THERE WERE NO MANUFACTURING ANOMALIES IDENTIFIED. THE DEVICE LOT MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 09/20/2022. IT IS UNKNOWN IF THE SYSTEM IMPLANT WAS DAMAGED POST-OPERATIVELY. POST-OPERATIVE IMPLANT MALFUNCTIONS ARE LISTED AS A POSSIBLE ADVERSE EVENT RELATED TO IMPLANTATION OF THE DEVICE IN THE SYSTEM IFU. THE SYSTEM IFU WARNS, "SURGERY MAY NOT REDUCE THE PREOPERATIVE PAIN EXPERIENCED" AND "FAILURE OF THE FUSION TO HEAL OR SPONTANEOUS FUSION." THERE HAVE BEEN ZERO OTHER COMPLAINTS OF SIMILAR NATURE IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR THIS PRODUCT FAMILY FOR COMPLAINTS FROM THE FIELD.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS MADE AWARE OF THIS ADVERSE EVENT ON 11/21/2024. IT WAS REPORTED THAT A PATIENT UNDERWENT DECOMPRESSION AND IMPLANTATION AT L4/L5 ON (B)(6) 2024, AND HAD SUBSEQUENT BACK PAIN DOCUMENTED ON (B)(6) 2024. LATERAL LUMBER X-RAYS WERE PERFORMED AND IT WAS NOTED THERE MAY BE PROGRESSION OF SPONDYLISTHESIS INDICATING INSTABILITY. THE SURGEON DISCUSSED THE OPTION TO REMOVE THE POSSIBLY FAILING DEVICE AND PERFORM FUSION IF NECESSARY, ALTHOUGH NO DECISION OR REVISION PROCEDURE HAS BEEN MADE YET. NEW MRI AND LUMBAR X-RAYS WERE ORDERED. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2115689 COFLEX INTERLAMINAR TECHNOLOGY Prosthesis, spinous process spacer/plate NQO XTANT MEDICAL HOLDINGS, INC UQI00012 2022002243

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other