BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM

    MDR report key: 6662687 · Received June 23, 2017

    Report

    Report Number
    1030489-2017-01617
    Event Type
    Injury
    Date Received
    June 23, 2017
    Report Date
    May 29, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    OVE
    UDI-DI
    00643169337435
    PMA / PMN Number
    K141599
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE (OVE): INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL (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.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: CERVICAL HERNIA. PROCEDURE: CERVICAL ANTERIOR FUSION IT WAS REPORTED THAT ON UNKNOWN DATE, POST-OP, THE IMPLANT GOT DEVIATED IN THE PATIENT'S BODY. A REVISION SURGERY WAS PERFORMED FOR FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445081 DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM OVE MDT SOFAMOR DANEK PUERTO RICO MFG NA H5217677 00643169337435

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention