BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI PSPC MATRIXMANDIBLE 20H PL 2.0MM THICK

    MDR report key: 3010191 · Received March 19, 2013

    Report

    Report Number
    2530088-2013-00345
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE REVIEW OF THE DESIGN HISTORY RECORD, ALL REQUIRED DOCUMENTS ARE PRESENT IN THE DHR UPON REVIEW OF THE RISK ANALYSIS AND FUNCTIONAL / DESIGN REQUIREMENT, IT WAS DETERMINED THAT THIS DEVICE MET THOSE REQUIREMENTS, AND THESE REQUIREMENTS DID NOT ATTRIBUTE TO THE COMPLAINT.

    Description of Event or Problem · 1

    DURING A PROCEDURE ON (B)(6) 2013, IT WAS REPORTED THAT THE PSPC - PATIENT SPECIFIC PLATE CONTOURING FOR THE PATIENT IS NOT USABLE. THE PLATE SITS TOO HIGH ON THE MANDIBLE. THE SURGERY TIME WAS EXTENDED BY AT LEAST 15 MINUTES. THE PLATE WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114672 TI PSPC MATRIXMANDIBLE 20H PL 2.0MM THICK JEY SYNTHES BRANDYWINE 7264926

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR