BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSX INTERBODY SYSTEM

    MDR report key: 16375962 · Received February 14, 2023

    Report

    Report Number
    2027467-2023-00009
    Event Type
    Injury
    Date Received
    February 14, 2023
    Date of Event
    January 16, 2023
    Report Date
    February 14, 2023
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    MAX
    UDI-DI
    00190376396781
    PMA / PMN Number
    K211873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION FINDINGS:4248. INVESTIGATION CONCLUSION: 61. H10. THIS INTERBODY WAS PLACED AND SAW POST-OPERATIVE COLLAPSE WHICH RESULTED IN A REVISION CAGE NECESSARY. FOLLOWING EXPLANATION, THE IMPLANT WAS SENT HERE FOR EVALUATION. BELOW IS A LIST OF THE FINDINGS THAT I SAW WHEN ANALYZING THE INTERBODY: THE RUNNING TORQUE OF THE IMPLANT (EXPANSION AND COLLAPSE DIRECTIONS) WAS MEASURED WITH TORQUE METER AND VALUES BETWEEN 0.50-0.80 IN-OZ WERE RECORDED ACROSS THE LENGTH OF THE EXPANSION DISTANCE. PER THE P/N 320-XXXXXX00 DRAWING AS STATED ON FLAG NOTE 2 (SHOWN BELOW) A MINIMUM OF 4.5 IN-OZ IS REQUIRED OF AN IN-SPECIFICATION INTERBODY. THIS SPECIFICATION IS ON THE QIR AND IS 100% INSPECTED ON ALL INCOMING INTERBODIES. THE ENGINEERING TEAM INVESTIGATED DAMAGE TO THE INTERBODY, SPECIFICALLY THE EXPANSION MECHANISM. THE DRIVE SCREW ANTI-COLLAPSE TINES ARE INTACT AND SEEM TO BE IN GOOD CONDITION. THERE IS GRAFT MATERIAL PRESENT, BUT THIS IS EXPECTED. THE DROP IN TORSIONAL RESISTANCE LIKELY OCCURRED AFTER THE INTERBODY WAS PLACED IN THE NON-STERILE SET CADDY AND THEN IMPLANTATION OF THE DEVICE. BECAUSE THE INTERBODY APPEARS TO BE STRUCTURALLY SOUND, THEN IT IS MOST LIKELY THAT A RELAXATION OF THE DRIVE SCREW TINES OCCURRED DURING THIS TIMEFRAME. THE ONLY MANNER IN WHICH THE ENGINEERING TEAM WAS ABLE TO REPLICATE THE DROP OF TORSIONAL RESISTANCE IS THE REPEATED MOTION OF FULLY EXPANDING AND COLLAPSING THE INTERBODY MULTIPLE TIMES. THEREFORE, IT SEEMS MOST LIKELY THAT THIS FAILURE MODE OCCURRED PRIOR TO THE IMPLANTATION OF THE CAGE AND STEMS FROM THE POTENTIAL REPEATED TESTING/DEMO OF THE INTERBODY PRIOR TO USE. LABELING REVIEW: "PREOPERATIVE MANAGEMENT: THE CONDITION OF ALL IMPLANTS AND INSTRUMENTS SHOULD BE CHECKED PRIOR TO USE. DAMAGED AND/OR WORN IMPLANTS AND INSTRUMENTS SHOULD NOT BE USED." "POSSIBLE ADVERSE EFFECTS: POSSIBLE ADVERSE EFFECTS INCLUDE: INITIAL OR DELAYED LOOSENING, BENDING, DISLOCATION, AND/OR BREAKAGE OF DEVICE COMPONENTS."

    Additional Manufacturer Narrative · 0

    NEITHER THE ORIGINAL SURGERY NOR REVISION SURGERY DATE WERE PROVIDED. THE IMPLANT IS CURRENTLY BEING EVALUATED. A FOLLOW-UP REPORT WITH THE RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 0

    IT WAS REPORTED AN INTERBODY CAGE COLLAPSED POSTOPERATIVELY. A REVISION SURGERY WAS PERFORMED TO REMOVE THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174255 PSX INTERBODY SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ALPHATEC SPINE, INC. 320-08102500 SM147911 00190376396781

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other