BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10151

    MDR report key: 3003668 · Received February 28, 2013

    Report

    Report Number
    2520274-2013-10151
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    May 12, 2011
    Product Code
    KTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 THIS EVENT AFTER FILING 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

    ACCORDING TO THE REPORTER, SURGEON HAD A PATIENT THAT WAS HAVING SOME KIND OF REACTION TO A PLATE AND SCREW IMPLANTATION ON AN UNKNOWN DATE. THE PATIENT WAS IMPLANTED WITH PLATES AND SCREWS FROM SYNTHES AND ALSO A DIFFERENT VENDOR (MFR). SURGEON NOTED THE INCISION ON THE PATIENT WAS SWOLLEN AND RED. PRODUCT IS STILL IMPLANTED AT THIS TIME. THIS COMPLAINT IS ON THE SYNTHES PLATE AND THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88210 KTT

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR SCREWS: MFR UNKNOWN| PLATES: MFR UNKNOWN