BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFERIOR PLATE

    MDR report key: 2982396 · Received February 26, 2013

    Report

    Report Number
    2530088-2013-10146
    Event Type
    Injury
    Date Received
    February 26, 2013
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE HISTORY RECORDS REVIEW CHECK LIST DID NOT SHOW ANY NON-CONFORMITY. VISUAL EXAMINATION NOTED THE DEVICE COATING DAMAGED CONSISTENT WITH IMPLANT REMOVAL. THE DEVICE WAS CONSISTENT WITH ALL DRAWING DIMENSIONS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE SURGEON PERFORMED A DISCECTOMY, AND ASSEMBLED THE IMPLANT ON THE INSERTER. HE INSERTED THE SUPERIOR AND INFERIOR PRODISC-L END PLATES. HE THEN INSERTED THE PRODISC-L POLY INLAY, BUT FELT THAT THE POLY INLAY DID NOT SEAT PROPERLY, AND DECIDED TO REMOVE IT. HE ALSO REMOVED BOTH OF THE END PLATES AS HE FELT THEY MAY BE COMPROMISED BY REMOVING THE INLAY ONLY. THE SURGEON THEN INSERTED ANOTHER SYNTHES PRODISC-L SET WITH NO COMPLICATIONS TO THE PATIENT. THE PROCEDURE WAS EXTENDED BY APPROXIMATELY 30 MINUTES TO EXPLANT THE FIRST SET AND IMPLANT THE SECOND SET. THIS COMPLAINT IS ON THE PRODISC-L SUPERIOR PLATE AND THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81789 INFERIOR PLATE MJO SYNTHES (USA) BRANDYWINE 6558403

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention