BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXMANDIBLE 7X23 ANGLE RECON PL RIGHT 2.5MM T

    MDR report key: 2782131 · Received October 4, 2012

    Report

    Report Number
    3003506883-2012-00297
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    August 9, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THE TI MATRIXMANDIBLE RECON PLATE REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS RECON PLATE LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED TWO (2) MATRIXMANDIBLE RECONSTRUCTION PLATES ON THE PATIENT'S STERNUM DURING A PECTUS EXCAVATUM PROCEDURE ON AN UNKNOWN DATE. SALES CONSULTANT ADVISED THE SURGEON THAT THIS WAS AN OFF-LABEL USE OF THESE PLATES. A FOLLOW-UP X-RAY TAKEN ON AN UNKNOWN DATE SHOWED THE PLATE(S) TO BE BROKEN. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF THE PLATES. THE STERNUM WAS HEALED AND NO REVISION WAS NECESSARY. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI MATRIXMANDIBLE 7X23 ANGLE RECON PL RIGHT 2.5MM T TI MATRIXMANDIBLE 7X23 ANGLE RECON PLATE JEY SYNTHES ELMIRA 6421397

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention