BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT

    MDR report key: 8177195 · Received December 18, 2018

    Report

    Report Number
    2031049-2018-00046
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    November 21, 2018
    Report Date
    December 18, 2018
    Manufacturer
    TMJ SOLUTIONS, INC.
    Product Code
    LZD
    UDI-DI
    B004TYYNNNNRM0
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT RECEIVED BILATERAL TMJ IMPLANTS IN (B)(6) 2018, WHICH INCLUDED A LEFORT 1 OSTEOTOMY AND ANTERIOR MANDIBULAR OSTEOTOMY WITH GENIOGLOSSUS ADVANCEMENT. IN 1997, THE PATIENT HAD A SEVERE LIFE-THREATENING ACCIDENT, WHICH RESULTED IN MULTIPLE FACIAL FRACTURES AND THE PATIENT HAS EXPERIENCED SIGNIFICANT PROBLEMS WITH HIS TM JOINTS AND AIRWAY OVER THE YEARS. AT THE TIME OF THE IMPLANT SURGERY, THE SURGEON HAD DIFFICULTY COMPLETING THE MOVEMENT OF THE MANDIBLE INTO ITS NEW POSITION DUE TO THE SEVERE AMOUNT OF SCARRING PRESENT WITHIN THE TM JOINTS. AFTER THE IMPLANTS WERE PLACED THERE WAS A SMALL DISCREPANCY IN THE OCCLUSION, WHICH WAS ADDRESSED WITH A DIAMOND BUR. ON (B)(6) 2018, THE SURGEON TOOK THE PATIENT BACK INTO SURGERY AND ELECTED TO REMOVE MORE BONE FOR BETTER ADAPTATION OF THE RIGHT MANDIBULAR COMPONENT AND REFIXATED THE DEVICE APPROPRIATELY WITH THE CONDYLE WITHIN THE RIGHT GLENOID FOSSA. THE PATIENT HAS SINCE BEEN SEEN BY HIS SURGEON AND IS CONSIDERED TO BE PROGRESSING WELL.

    Description of Event or Problem · 1

    THE PATIENT'S RIGHT TMJ MANDIBULAR COMPONENT WAS REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016327 PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT RIGHT MANDIBULAR COMPONENT LZD TMJ SOLUTIONS, INC. TYY-NNNNRM W46482 B004TYYNNNNRM0

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention