BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSX

    MDR report key: 15655807 · Received October 21, 2022

    Report

    Report Number
    2027467-2022-00075
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    September 22, 2022
    Report Date
    September 22, 2022
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K211873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPLANT HAS NOT RETURNED FOR EVALUATION. A RADIOGRAPH WAS PROVIDED WHICH CONFIRMED THE EVENT. NEITHER THE IDENTIFYING PART NOR LOT NUMBER WERE PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE ORIGINAL SURGERY DATE IS UNKNOWN.. IF ADDITIONAL INFORMATION IS PROVIDED, SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFO: D4. MODEL # 320-10102500. CATALOG # 320-10102500. LOT # SM149006. UNIQUE IDENTIFIER (B)(4). 6B. 10/06/2022. 9. YES. H3. YES. H4. 04/15/2022. H6. TYPE OF INVESTIGATION: 10, 3331. INVESTIGATION FINDINGS: 213. INVESTIGATION CONCLUSION: 4310. H10: THE FOLLOWING INFORMATION WAS PROVIDED BY THE SALES REPRESENTATIVE AFTER REMOVAL OF THE CAGE. THE CAGE APPEARED NORMAL WITH IMPRESSIVE GRAFT BACKFILL. AT THIS POINT THE LIKELY CULPRIT APPEARS TO BE INSTABILITY AT L5-S1 AS EVIDENCED BY THE SIGNIFICANT "HALO-ING" OF THE ORIGINAL SCREWS (7.5X50MM). THE S-1 SCREWS WERE COMPLETELY WALLED OUT AFTER ONLY SIX WEEKS. 10.5S WOULDN'T EVEN TOUCH ONE OF THE SIDES. THE SURGEON REVISED THE PATIENT WITH ILIAC BOLTS AND AN ALIF. MANUFACTURING REVIEW: THE RETURNED INTERBODY THERE DOES NOT SEEM TO BE A FAILURE OF THE INTERBODY ITSELF. ALL COMPONENTS SEEM TO BE INTACT AND ASSEMBLED CORRECTLY. THE IMPLANT WAS TESTED FOR TORSIONAL RESISTANCE AND THE PASSIVE LOCKING MECHANISM OF THE EXPANSION MECHANISM MAINTAINS SUFFICIENT DRAG TO COMBAT IN-SITU COLLAPSE. THE ROOT CAUSE IS A LACK OF SUFFICIENT COMPRESSIVE FORCE POSTERIORLY ON THE CAGE AFTER IMPLANTATION, WHICH IS OUTSIDE THE SCOPE OF THE INTERBODY SPACER ITSELF.

    Description of Event or Problem · 0

    IT WAS REPORTED A CAGE AT L5-S1 MIGRATED POSTERIORLY. A SURGERY HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2463109 PSX INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ALPHATEC SPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other