BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SV1995-220829 RT PM-TMJ & MOD

    MDR report key: 21632597 · Received March 18, 2025

    Report

    Report Number
    0001032347-2025-00132
    Event Type
    Injury
    Date Received
    March 18, 2025
    Report Date
    September 29, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    UDI-DI
    00888233066273
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). 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 FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H4, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE DESIGNER OF THIS DEVICE, 3D SYSTEMS, WAS NOTIFIED OF THIS COMPLAINT AND AN INVESTIGATION WAS CONDUCTED. IT WAS A KNOWN CONCERN THAT THE FACIAL NERVE WAS CLOSE TO THE FOSSA AND THE SURGEON APPROVED THE IMPLANT DESIGN. THE COMPLAINT WAS THAT THE FOSSA IMPLANT WAS TOO LARGE, HOWEVER, A DESIGN REVIEW CONCLUDED THAT THE DEVICE WAS WITHIN THE SPECIFICATIONS SET FORTH FOR THE DEVICE. IT WAS NOTED THAT THE DEVICE PLANNING BEGAN IN 2022 AND THE COMPLAINT OCCURRED IN 2025, WHICH MEANS IT IS POSSIBLE THAT PATIENT ANATOMY CHANGED BETWEEN THE SCAN DATE AND IMPLANT DATE. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE PATIENT UNDERWENT A CUSTOM TMJ PROCEDURE. DURING THIS PROCEDURE IT WAS DIFFICULT AND LONG ACCESS TO THE FOSSA DUE TO THE SPECIAL ANATOMY. AS USUAL, THE EXTENT OF THE FOSSA WAS UNCOMFORTABLY LARGE AND WAS CRITICIZED. THE ANTERIORLY DISPLACED EXIT POINT OF THE FACIAL NERVE WAS EXTREMELY CLOSE TO THE POSTERIOR EDGE OF THE FOSSA. SURGEON CAME INTO THE OPERATING ROOM AND VISUALIZED THE NERVE. INTRAOPERATIVE WEB MEETING WITH PRODUCT ADVISOR CONFIRMED THAT THE PLANNING OF THE LOCATION OF THE FOSSA WAS SYNCHRONIZED WITH THE OPPOSITE SIDE AND THE NERVE EXIT/COURSE WAS APPROVED BY THE DOCTOR. IN CONSULTATION WITH ALL SURGEONS, THE SURGERY WAS ABORTED BECAUSE A LESION OF THE FACIAL NERVE WAS TOO LIKELY WITH IMPLANTATION OF THE FOSSA AND THIS RISK WAS DISPROPORTIONATE TO THE SURGICAL OUTCOME. THE PROSTHESIS WAS ORIGINALLY PLANNED BY THE SURGEON APPROXIMATELY THREE YEARS AGO AND DELIVERED AT THE BEGINNING OF TWO YEARS AGO. THE PATIENT SUBSEQUENTLY BECAME PREGNANT AND WAS ONLY NOW ABLE TO UNDERGO SURGERY.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537151 SV1995-220829 RT PM-TMJ & MOD JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION 166810 00888233066273

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention