BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-00231

    MDR report key: 2905682 · Received January 9, 2013

    Report

    Report Number
    2520274-2013-00231
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    June 9, 2010
    Report Date
    January 10, 2011
    Manufacturer
    SYNTHES
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THE EXACT PART NUMBER COULD NOT BE IDENTIFIED. DEVICE WAS NOT RETURNED TO MANUFACTURING. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    EU COMPLAINT HANDLING UNIT REPORTED A PATIENT HAD A REVISION OF AN ANTERIOR CERVICAL DISCECTOMY AT C5-7, PARTIAL CORPECTOMY OF C5-7, REMOVAL OF A PRODISC C6-7, PEEK CAGES AT C5-7 AND TRESTLE PLATE FIXATION AT C5-7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11122 MJO SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention