BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELAMON FUSION DEVICE

    MDR report key: 5849445 · Received August 5, 2016

    Report

    Report Number
    1030489-2016-02281
    Event Type
    Injury
    Date Received
    August 5, 2016
    Report Date
    July 11, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN US BUT A SIMILAR DEVICE WITH CATALOG # 4201422 AND 510K# K110562 IS APPROVED FOR SALE IN US. NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH L4 BURST FRACTURE UNDERWENT POSTERIOR LUMBAR FUSION AND VERTEBRAL COLUMN RESECTION.ON AN UNKNOWN DATE, POST-OP, THE PLACED PEEK CAGE SUBSIDED IN THE VERTEBRAL BODY. REVISION SURGERY WAS PERFORMED TO EXTEND FIXATION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501569 TELAMON FUSION DEVICE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention