BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXMANDIBLE 7X23 ANGLE RECON PL RIGHT 2.8MM THICK

    MDR report key: 3143484 · Received June 3, 2013

    Report

    Report Number
    3003506883-2013-00245
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATED. AS RECEIVED, THE PLATE WAS BROKEN INTO TWO PARTS. THE LARGE PART HAS BEEN BROKEN/CUT AT BOTH ENDS; ABOVE THE SECOND HOLE OF THE CONDULAR END FROM THE 4-HOLE ANGLE SECTION, AND AFTER THE EIGHTH HOLE ON THE STRAIGHT END FROM THE 4-HOLE ANGLE SECTION. THE SECOND PART IS A SINGLE HOLE THAT HAS BEEN CUT/BROKEN ON BOTH SIDES. THE SINGLE HOLE PART APPEARS TO HAVE MOST LIKELY BROKEN OFF THE STRAIGHT END OF THE PLATE BETWEEN THE EIGHTH AND NINTH HOLES FROM THE 4-HOLE ANGLE SECTION. THE PLATE HAS BEEN BENT/CONTOURED ALONG THE ENTIRE LENGTH AND THERE ARE MANY INDENTATIONS ALONG THE PLATE WHERE TOOLS HAVE BEEN USED TO CLAMP THE PLATE DURING CONTOURING. ALL FEATURES RELEVANT TO THE COMPLAINT WERE MEASURED AND WERE FOUND TO BE WITHIN SPECIFICATION. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DATE DEVICE RECEIVED WAS CHANGED FROM (B)(6) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A MANDIBLE RESECTION PROCEDURE ON (B)(6) 2013, THE SURGEON BROKE THE 2.9MM MANDIBLE PLATE DURING THE BENDING PROCESS. A 2.5MM PLATE WAS USED AS A REPLACEMENT SINCE A 2.9MM PLATE WAS NOT AVAILABLE. THE PROCEDURE WAS DELAYED BETWEEN FORTY FIVE MINUTES AND AN HOUR WHILE THE PATIENT WAS UNDER ANESTHESIA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242921 TI MATRIXMANDIBLE 7X23 ANGLE RECON PL RIGHT 2.8MM THICK JEY SYNTHES ELMIRA 7081093

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention