BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOCKING RECON PLATE 6 X 23 HOLES/44MM X 214MM-LEF

    MDR report key: 2704058 · Received August 10, 2012

    Report

    Report Number
    1719045-2012-00831
    Event Type
    Injury
    Date Received
    August 10, 2012
    Date of Event
    June 30, 2012
    Report Date
    July 13, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    K961421
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    PATIENT WAS IMPLANTED WITH A 2.4MM LRC 6X23 PLATE ON THE LEFT SIDE OF THE MANDIBLE ON (B)(6) 2011. IT IS REPORTED THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF THE PLATE DUE TO BREAKAGE AT THE STRAIGHT PORTION OF THE PLATE. PATIENT REPORTED THIS OCCURRED AS HE ATE A TORTILLA. SURGEON REPORTS PLATE WAS BROKEN ON THE STRAIGHT END OF THE PLATE AND ALL SCREWS WERE INTACT ON THE BODY AND CONDYLAR ASPECTS. PATIENT WAS REVISED TO TI LOCKING RECONSTRUCTION PLATE CONSTRUCT AND BONE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI LOCKING RECON PLATE 6 X 23 HOLES/44MM X 214MM-LEF TI LOCKING RECON PLATE JEY SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention