BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSE CAGE

    MDR report key: 3230227 · Received July 16, 2013

    Report

    Report Number
    3003529816-2013-00048
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    July 10, 2013
    Report Date
    December 3, 2013
    Manufacturer
    ADVANCED MEDICAL TECHNOLOGIES
    Product Code
    MAX
    PMA / PMN Number
    K100945
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT VISUAL REVIEW CONFIRMS IMPLANT BROKEN, WITH APPROXIMATELY IN 30% OF THE IMPLANT RETURNED FOR ANALYSIS. OPTICAL EXAMINATION IDENTIFIED DEFORMATION OF THE IMPLANT INSERTER INTERFACE FEATURES; ADDITIONALLY THE SAGITTAL SURFACE IMMEDIATELY ADJACENT TO THE FRACTURE SURFACES ARE TWISTED, CONSISTENT WITH TORSIONAL OVERLOAD. FRACTURE SURFACES APPEAR TO DISPLAY QUASI-DUCTILE FRACTURE SURFACES CONSISTENT WITH OVERLOAD. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH OVERLOAD, RESULTING IN THE FOREGOING EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE CAGE WAS INSERTED, THE TOP BROKE OFF. THE REST OF THE CAGE REMAINED IN THE PATIENT. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328564 FUSE CAGE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ADVANCED MEDICAL TECHNOLOGIES 11062FO

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR