BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSX INTERBODY SYSTEM

    MDR report key: 21930784 · Received April 29, 2025

    Report

    Report Number
    2027467-2025-00064
    Event Type
    Injury
    Date Received
    April 29, 2025
    Date of Event
    March 31, 2025
    Report Date
    April 29, 2025
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K211873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4. MODEL #: 420-PRO-10102500-S. CATALOG #: 420-PRO-10102500-S. PRIMARY UDI: (B)(4). CORRECTION: D1. CALIBRATE NANOTEC PSX INTERBODY SYSTEM. G4. PMA/510(K): K231438.

    Additional Manufacturer Narrative · 0

    THE IMPLANT REMAINS IN SITU. REVISION SURGERY IS PLANNED. PHOTOGRAPHS WERE PROVIDED WHICH CONFIRM THE EVENT OF A COLLAPSED CAGE. THE PART AND LOT NUMBER WERE NOT PROVIDED; THEREFORE, A REVIEW OF DEVICE HISTORY RECORDS CANNOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE COULD NOT BE DETERMINED. 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. POSSIBLE ADVERSE EFFECTS: INITIAL OR DELAYED LOOSENING, BENDING, DISLOCATION, AND/OR BREAKAGE OF DEVICE COMPONENTS. POSTOPERATIVE MANAGEMENT: THE SURGEON SHOULD INSTRUCT THE PATIENT REGARDING THE AMOUNT AND TIME FRAME AFTER SURGERY OF ANY WEIGHT BEARING ACTIVITY. THE INCREASED RISK OF BENDING, DISLOCATION, AND/OR BREAKAGE OF THE IMPLANTED DEVICES, AS WELL AS AN UNDESIRED SURGICAL RESULT ARE CONSEQUENCES OF ANY TYPE OF EARLY OR EXCESSIVE WEIGHT BEARING, VIBRATORY MOTION, FALLS, JOLTS OR OTHER MOVEMENTS PREVENTING PROPER HEALING AND/OR FUSION DEVELOPMENT. IMPLANTED DEVICES SHOULD BE REVISED OR REMOVED IF BENT, DISLOCATED, OR BROKEN. IMMOBILIZATION SHOULD BE CONSIDERED IN ORDER TO PREVENT BENDING, DISLOCATION, OR BREAKAGE OF THE IMPLANTED DEVICE IN CASE OF DELAYED, MALUNION, OR NONUNION OF BONE. IMMOBILIZATION SHOULD CONTINUE UNTIL A COMPLETE BONE FUSION MASS HAS DEVELOPED AND BEEN CONFIRMED.

    Description of Event or Problem · 0

    AT THE 6-WEEK POSTOPERATIVE VISIT, THE PATIENT WAS PRESENTING WITH RIGHT SIDE RADICULAR SYMPTOMS. IT WAS REPORTED THAT THE EXPANDABLE CAGE HAD COLLAPSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1595731 PSX INTERBODY SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ALPHATEC SPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention