BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI COMPRESSION TENSION BAND PLATE 6 HOLES/36MM

    MDR report key: 3053430 · Received April 11, 2013

    Report

    Report Number
    3003506883-2013-10097
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    June 11, 2012
    Report Date
    June 11, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    JEY
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    NURSE

    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.

    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 FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE FOR A MANDIBLE FRACTURE, THE SURGEON BENT THE PLATE BOTH IN-PLANE AND OUT-OF-PLANE. THE PLATE BROKE AT THE TOP OF ONE OF THE HOLES WHEN THE SURGEON ATTEMPTED TO INSERT A SCREW. THE SURGEON REMOVED THE PLATE AND USED ANOTHER TO COMPLETE THE PROCEDURE. THE BROKEN PLATE WAS DISCARDED AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156729 2.4MM TI COMPRESSION TENSION BAND PLATE 6 HOLES/36MM JEY SYNTHES ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR