BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-L IMPLANT POLYETHYLENE INLAY

    MDR report key: 2021631 · Received March 10, 2011

    Report

    Report Number
    8030965-2011-00066
    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 INFO HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MFG DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PT IMPLANTED WITH PRODISC-L ON (B)(6) 2011. OUTCOME OF SURGERY REPORTED AS GOOD AND PT PAIN FREE. ONE WEEK FOLLOW UP, IMPLANT HAD SUBSIDED INTO THE ENDPLATE OF L5. PT WAS ASYMPTOMATIC. REPORTEDLY, PT DENIED ANY INCIDENCES. THIS IS THE 3RD OF 3 REPORTS SUBMITTED ON THIS EVENT.

    Devices

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

    Patients

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