BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMANDIBLE PREFORMED RECON PL/SMALL/RIGHT/2.5MM THK

    MDR report key: 3070097 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10927
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    June 26, 2012
    Report Date
    June 29, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K113251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. MANUFACTURING SITE ADDRESS IS UNKNOWN. PLACEHOLDER.

    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

    IT WAS REPORTED THAT DURING A MANDIBULAR RECONSTRUCTION PROCEDURE THE SURGEON WAS BENDING THE PLATE, PRIOR TO IMPLANTATION, AND IT BROKE INTO 2 PIECES. THERE WERE NO PIECES TO RETRIEVE AND THE SURGEON COMPLETED THE SURGERY WITH A NEW PLATE WITH NO FURTHER INCIDENT. NO ADVERSE EFFECT TO PATIENT WAS NOTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171880 TI MATRIXMANDIBLE PREFORMED RECON PL/SMALL/RIGHT/2.5MM THK JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1