BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM TMJ SYSTEM LT PMTMJ & MODEL

    MDR report key: 21559943 · Received March 10, 2025

    Report

    Report Number
    0001032347-2025-00113
    Event Type
    Injury
    Date Received
    March 10, 2025
    Date of Event
    January 14, 2025
    Report Date
    July 24, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    UDI-DI
    00888233078313
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). G2: FOREIGN SOURCE: UNITED KINGDOM. G4: SIMILAR US PRODUCT: P020016. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS A1, A2, B4, B5, D4, E1, G3, G6, H2, AND H11.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND/OR CORRECTED INFORMATION. UPDATED: B5, H2, H3, H6 AND H11. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER AND PRODUCT WAS NOT RETURNED. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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

    IT IS REPORTED THAT DURING A TEMPOROMANDIBULAR JOINT PROCEDURE, THE FOSSA IMPLANT SAMPLE WAS IMPLANTED. THIS WAS DISCOVERED AT THE COMPLETION OF THE CASE. THE PATIENT WAS RETURNED TO THEATER PRIOR TO THE PATIENT LEAVING THE THEATER SUITE AND THE FOSSA IMPLANT SAMPLE WAS REMOVED AND REPLACED WITH THE FOSSA IMPLANT. THIS WAS COMPLETED SUCCESSFULLY. THERE WAS NO ISSUE WITH THE PACKAGING OF THE IMPLANT AND FOSSA IMPLANT SAMPLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452038 CUSTOM TMJ SYSTEM LT PMTMJ & MODEL JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION 67013076 00888233078313

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H