BEUDAMED
    FDA Adverse Event Summary report: N

    MANDIBULAR PROSTHETIC

    MDR report key: 39462 · Received June 18, 1996

    Report

    Report Number
    MW4001510
    Date Received
    June 18, 1996
    Date of Event
    June 29, 1992
    Report Date
    June 18, 1996
    Manufacturer
    OSTEOMED CORP.
    Product Code
    LZD
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON 6/29/92 RPTR HAD A BILATERAL MANDIBULAR JOINT RECONSTRUCTION. NOV OF 1993 RPTR DEVELOPED SWELLING IN HER RIGHT HIP. RPTR ALSO UNABLE TO DO REGULAR AEROBICS AND HAD TO HAVE EXTENSIVE PHYSICAL THERAPY AND CORTISONE INJECTIONS IN THE RIGHT TMJ. RPTR ALSO EXPERIENCED HEEL SWELLING AND PAIN AND NECK AND LEFT HIP JOINT INFLAMMATION. SHE WAS TREATED WITH CORTISONE INJECTIONS. SHE WAS REFERRED TO SEVERAL SPECIALISTS AND UNDERWENT SEVERAL TESTS. SHE HAS BEEN PRESCRIBED MULTIPLE MEDICATIONS WITH SOME SIDE EFFECTS. RPTR HAS HAD TO RETIRE. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANDIBULAR PROSTHETIC MANDIBULAR PROSTHETIC LZD OSTEOMED CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *