BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    MDR report key: 8658543 · Received May 31, 2019

    Report

    Report Number
    0001032347-2019-00309
    Event Type
    Injury
    Date Received
    May 31, 2019
    Date of Event
    May 2, 2019
    Report Date
    September 13, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THERE WAS A REVISION TO REMOVE AND REPLACE THE SCREW, THEREFORE, THE COMPLAINT IS CONSIDERED CONFIRMED. FUNCTIONAL TESTING AND INSPECTIONS COULD NOT BE PERFORMED DUE TO THE PART NOT BEING RETURNED AND NO PHOTOGRAPHS, X-RAYS, CT SCANS, OR PHYSICIAN REPORTS BEING PROVIDED. THE DHR COULD NOT BE REVIEWED DUE TO THE PART AND LOT NUMBER BEING UNKNOWN. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. BASED ON THE INFORMATION AND MATERIALS PROVIDED, THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE PART NUMBER OF THE SCREW WAS NOT PROVIDED. THEREFORE, THE 510K CANNOT BE DETERMINED. THERE ARE TWO POSSIBLE 510K NUMBERS FOR SCREWS INTENDED FOR USE WITH THE TMJ SYSTEM, K910038 AND K113512. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NUMBNESS IN THEIR LIP. THEREFORE, THE PATIENT UNDERWENT A REVISION TO REMOVE AND REPLACE A TMJ SCREW THAT WAS NEAR A NERVE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450921 TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM SCREW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKNOWN TMJ PROSTHESIS, CATALOG#: NI, LOT#: NI| UNKNOWN TMJ PROSTHESIS, CATALOG#: NI, LOT#: NI