BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMANDIBLE DCP 2+2HO T1.5 TI

    MDR report key: 3251245 · Received July 29, 2013

    Report

    Report Number
    2520274-2013-04590
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 2, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE PARTS WERE MANUFACTURED IN (B)(4) AS NON-STERILE PARTS, LOT NUMBER 6266857. THE DEVICE HISTORY REVIEW COMPLETED ON 7/23/2013 INDICATES NO ABNORMALITIES WITH THE MANUFACTURE, PIECE COUNTS, PARTS TRACKING OR PACKAGING AND LABELING. THE ADDITIONAL EVALUATION INVESTIGATION COMPLETED ON 1/13/2014 REPORTED THE FAILURE COULD BE DETECTED AS A MIX-UP LABELING FAILURE, THROUGH-OUT THE LABELING PROCESS. THE LABELING PROCESS FOR THIS SCREW WOULD NOW BE PROVIDED BY AN EXTERNAL SUPPLIER. THE COMPLAINT WAS DETERMINED TO BE VALID.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE LABEL SHOWS 449.915S, LOT 3373620. WHEN THE SURGEON OPENED THIS PACKAGE IN THE OPERATION, HE FOUND IT INCLUDED SEALS DESCRIBED FOR ANOTHER DEVICE LABEL. (449.915S, LOT 3373620). PACKAGE AND DESCRIPTION SHEET RECEIVED AND SENT JULY 15,2013. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353097 MATRIXMANDIBLE DCP 2+2HO T1.5 TI JEY SYNTHES USA 3373621

    Patients

    Seq Age Sex Outcome Treatment
    1