BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

    MDR report key: 8187940 · Received December 20, 2018

    Report

    Report Number
    2031049-2018-00049
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    November 12, 2018
    Report Date
    December 20, 2018
    Manufacturer
    TMJ SOLUTIONS, INC.
    Product Code
    LZD
    UDI-DI
    B004TYYNNNNM0
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2012, THE PATIENT RECEIVED LEFT TMJ IMPLANTS, AND IN 2013 SHE RECEIVED RIGHT TMJ IMPLANTS. IN 2014, THE PATIENT DEVELOPED PERSISTENT PAIN AND SWELLING AND UNDERWENT A WASHOUT OF HER LEFT TMJ, BUT THIS DID NOT RESOLVE HER SYMPTOMS. IN 2016, A BIOPSY WAS TAKEN AND THE CULTURES TESTED POSITIVE FOR P. ACNES AND COAGULASE NEGATIVE STAPH. THE LEFT TMJ DEVICES WERE SUBSEQUENTLY REMOVED IN (B)(6) 2016, AND AN ANTIBIOTIC PLACER WAS PLACED. ONCE THE INFECTION HAD RESOLVED, REVISION IMPLANTS WERE PLACED IN (B)(6) 2017. THE PATIENT'S SYMPTOMS RETURNED IN 2018, AND ON (B)(6) 2018, THE SURGEON REMOVED THE PATIENT'S LEFT TMJ DEVICES AND PLACED AN ANTIBIOTIC SPACER. THE SURGEON PLANS ON PLACING REVISION COMPONENTS ONCE THE INFECTION HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    THE PATIENT'S LEFT TMJ DEVICES WERE REMOVED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026362 PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TEMPOROMANDIBULAR JOINT IMPLANT LZD TMJ SOLUTIONS, INC. TYY-NNNNM W38042 B004TYYNNNNM0

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention