BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSX

    MDR report key: 15591903 · Received October 12, 2022

    Report

    Report Number
    2027467-2022-00069
    Event Type
    Injury
    Date Received
    October 12, 2022
    Date of Event
    September 13, 2022
    Report Date
    September 13, 2022
    Manufacturer
    ALPHATEC SPINE, INC
    Product Code
    MAX
    UDI-DI
    00190376396798
    PMA / PMN Number
    K211873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RADIOGRAPH WAS PROVIDED WHICH CONFIRMED THE EVENT. VISUAL INSPECTION OF THE CAGE FOUND IT IS FULL OF BONE GRAFT AND FULLY CLOSED INDICATING THE SURGEON WAS ABLE TO COLLAPSE THE CAGE IN-SITU DURING THE REMOVAL PROCESS. AFTER REMOVING SOME OF THE BONE GRAFT MATERIAL THAT WAS DRIED WITHIN THE CONSTRUCT THERE SEEMED TO BE NO ISSUES THAT WERE PRESENT. THE CAGE WAS ABLE TO BE EXPANDED AND FUNCTIONED AS INTENDED. THERE WAS SUFFICIENT TORSIONAL RESISTANCE DURING THE EXPANSION PROCESS AND ALL THE DRIVE SCREW ANTI-COLLAPSE TINES WERE IN PLACE. THE ROOT CAUSE IS LIKELY A RESULT OF THE PLACEMENT OF THE INTERBODY INTO THE DISC SPACE BY THE USER. LABELING REVIEW: "WARNINGS/CAUTIONS: POTENTIAL RISKS IDENTIFIED WITH THE USE OF THESE FUSION DEVICES, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE DEVICE COMPONENT FAILURE, LOSS OF FIXATION, PSEUDARTHROSIS (I.E., NON-UNION), FRACTURE OF THE VERTEBRA, NEUROLOGICAL INJURY, AND/OR VASCULAR OR VISCERAL INJURY; PRECAUTIONS:ADDITIONAL CARE SHOULD BE TAKEN TO ENSURE A THOROUGH DISCECTOMY IS COMPLETED IN ORDER TO CORRECTLY SIZE, PLACE, AND EXPAND THE DEVICE. AN INCOMPLETE DISCECTOMY MAY RESULT IN DIFFICULTY TO FULLY DEPLOY AND PLACE THE DEVICE IN ITS INTENDED POSITION..;POSSIBLE ADVERSE EFFECTS:POSSIBLE ADVERSE EFFECTS INCLUDE: 1. INITIAL OR DELAYED LOOSENING, BENDING, DISLOCATION, AND/OR BREAKAGE OF DEVICE COMPONENTS...7. SUBSIDENCE OF THE DEVICE INTO THE VERTEBRAL BODY."

    Description of Event or Problem · 0

    DURING A POSTOPERATIVE VISIT, A RADIOGRAPH INDICATED THE CAGE HAD MIGRATED POSTERIORLY. THE PATIENT REPORTED BACK PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1888584 PSX INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ALPHATEC SPINE, INC 320-08103000 00190376396798

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention