BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C SIZ L H6

    MDR report key: 2912615 · Received January 13, 2013

    Report

    Report Number
    2520274-2013-00291
    Event Type
    Injury
    Date Received
    January 13, 2013
    Date of Event
    November 9, 2010
    Report Date
    December 16, 2010
    Manufacturer
    SYNTHTES
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT. 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 REVISION. THE PATIENT HAD AN INCIDENT IN SEGMENT C6-7. DURING DIAGNOSIS BY A NEUROLOGIST, IS WAS DETECTED THAT THE POSITION OF THE PRODISC-C IMPLANT C5-6 WAS TOO MUCH POSTERIOR PLACED. THE SURGEON DECIDED TO DO A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19631 PRODISC-C SIZ L H6 PRODISC-C SIZ L H6 MJO SYNTHTES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention