BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODISC-O PE-INLAY W/X-RAY MARKER SIZ M

    MDR report key: 2970605 · Received February 20, 2013

    Report

    Report Number
    2520274-2013-01069
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    March 10, 2010
    Report Date
    March 16, 2010
    Manufacturer
    SYNTHES
    Product Code
    MJO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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

    (B)(4) COMPLAINT HANDLING UNIT REPORTED A PRODISC O IMPLANT FAILURE. THE SURGERY WAS IMPLEMENTED WITHOUT INCIDENT UNTIL THE FOLLOWING STAGES. THE PE INLAY, INSERTER 03.821.143 WITH 10MM DISTRACTOR 03.821.151, WAS INSERTED. THE PE INSERTER WAS INSERTED AS FAR AS IT COULD GO AND PUSHED THE PE INLAY INTO THE CAUDAL IMPLANT. THE PE INLAY WAS HANGING OVER THE CAUDAL IMPLANT BY APPROXIMATELY 2MM. THERE WAS ALSO A GAP BETWEEN THE PE AND THE CAUDAL IMPLANT. THE SURGEON ATTEMPTED TO CONTINUALLY INSERT THE PE INLAY, BUT THE PE INLAY WAS BECOMING DAMAGED AS A RESULT OF CONTINUOUS ATTEMPTS TO PUSH IT INTO THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74605 PRODISC-O PE-INLAY W/X-RAY MARKER SIZ M PRODISC-O PE-INLAY W/X-RAY MARKER MJO SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1