BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSKER TMI-SYSTEM

    MDR report key: 258433 · Received January 10, 2000

    Report

    Report Number
    1032347-2000-00001
    Event Type
    Injury
    Date Received
    January 10, 2000
    Date of Event
    December 7, 1999
    Report Date
    January 10, 2000
    Manufacturer
    MEDICAL RESEARCH B V
    Product Code
    MPL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 1993, PT HAD BOSKER TMI IMPLANTED. ON 12/07/99 PT'S SPOUSE REPORTED THAT THE IMPLANT HAD BROKEN. REVISION IS SCHDULED IN 2000. REVISION IS TO INCLUDE BONE GRAFT(S) AND DENTAL IMPLANT(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSKER TMI-SYSTEM TRANSMANDIBULAR IMPLANT PROSTHESIS MPL MEDICAL RESEARCH B V NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention