BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODISC-C NOVA IMPLANT-STERILEXLD5 - EXTRA LARGE DEEP 5MM

    MDR report key: 2970607 · Received February 20, 2013

    Report

    Report Number
    2520274-2013-01084
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    November 19, 2010
    Manufacturer
    SYNTHES
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. 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)(6) REPORTED A BROKEN INLAY. THE IMPLANT WAS DAMAGED DURING HAMMERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74736 PRODISC-C NOVA IMPLANT-STERILEXLD5 - EXTRA LARGE DEEP 5MM PRODISC-C NOVA IMPLANT MJO SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1