BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10149

    MDR report key: 3003518 · Received February 28, 2013

    Report

    Report Number
    2520274-2013-10149
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    May 5, 2011
    Product Code
    MJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 THIS EVENT AFTER FILLING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    THE LEGAL DEPARTMENT REPORTED TO THE COMPLAINT UNIT THEY REC'D A CALL FROM A PT: PT STATUS POST PRODISC-L IMPLANTATION (B)(6) 2010, REPORTED A POSSIBLE ALLERGIC REACTION TO THE PDL IMPLANTATION. PT STATED SHE STARTED TO "PUFF UP" 3 WEEKS AFTER IMPLANTATION AND IT WAS INITIALLY THOUGH IT WAS A REACTION TO THE MEDICATIONS. A YEAR LATER AND THE PT IS STILL SWOLLEN. PT WOULD LIKE TO RULE OUT THE PDL IMPLANTATION AND IS REQUESTING HELP IN GETTING MATERIAL/INFO FOR PATCH TESTING. THIS COMPLAINT IS ON THE INFERIOR PLATE AND THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87032 MJO

    Patients

    Seq Age Sex Outcome Treatment
    1