BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELAMON® FUSION DEVICE

    MDR report key: 2681175 · Received August 3, 2012

    Report

    Report Number
    1030489-2012-01328
    Event Type
    Injury
    Date Received
    August 3, 2012
    Date of Event
    July 6, 2012
    Report Date
    July 6, 2012
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    NA
    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 THE UNITED STATES; HOWEVER A LIKE DEVICE WITH A PRODUCT CODE MAX WAS CLEARED IN THE UNITED STATES. (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE PMA # K110562 WAS CLEARED IN THE UNITED STATES. 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.

    Description of Event or Problem · 1

    A PATIENT WITH SEVERE SPONDYLOLISTHESIS UNDERWENT A PROCEDURE AT L5-S VIA PLIF. IT WAS REPORTED THAT A CAGE, WHICH WAS PLACED FIRST FROM RIGHT SIDE, MIGRATED ANTERIORLY WHEN INSERTING THE SECOND CAGE FROM LEFT SIDE. A REVISION SURGERY WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELAMON® FUSION DEVICE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG NA H11C4520

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention