BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-L IMPLANT INFERIOR

    MDR report key: 2021618 · Received March 10, 2011

    Report

    Report Number
    8030965-2011-00063
    Event Type
    Injury
    Date Received
    March 10, 2011
    Report Date
    February 14, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    MJO
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    DEVICE REPORT RECEIVED FROM SYNTHES (B)(4). PATIENT IMPLANTED WITH PRODISC-L UNDERWENT REVISION. THIS IS THE 2ND OF 3 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC-L IMPLANT INFERIOR PRODISC-L IMPLANT MJO SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention POLYETHYLENE INLAY| SUPERIOR PLATE