BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-00310

    MDR report key: 2913804 · Received January 14, 2013

    Report

    Report Number
    2520274-2013-00310
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    January 27, 2011
    Manufacturer
    SYNTHES
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. ADDITIONAL NARRATIVE: NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    EU COMPLAINT HANDLING UNIT REPORTED A REVISION. NO MATERIAL FOR INVESTIGATION WAS RECEIVED. A PRODISC-L REVISION WAS PERFORMED DUE TO ONGOING PAIN, LEVEL L5-S1. THE PRODISC-L WILL BE REPLACED WITH A SYNFIX. A PRODISC-L, SIZE M, 6 DEGREES, 10MM WAS IMPLANTED. A PLANNED REVISION DATE ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20006 MJO SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention