BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM MADE DEVICE PM-TMJ & MODEL

    MDR report key: 8638222 · Received May 23, 2019

    Report

    Report Number
    0001032347-2019-00297
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    January 9, 2019
    Report Date
    September 10, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT CANNOT BE VERIFIED, AS THE PRODUCT REMAINS IMPLANTED AND THE CUSTOMER DID NOT PROVIDE POST-OPERATIVE CT DATA. UPON REVIEW OF THE DIGITAL DESIGN FILES, THE VENDOR CONCLUDED THE FINAL SPLINT, MANDIBULAR AND FOSSA COMPONENT SAMPLES, AND GUIDES WERE DESIGNED ACCORDING TO ALL APPLICABLE PROCEDURES PER WI 470-500 TMJ COMPONENT DESIGN. ALL OF THE COMPONENTS OF TMJPM-2347 (B)(4)) WERE INSPECTED FOR SHAPE AND FIT AS PER LI0859 & LI0860 BY TRAINED ZB ENGINEERING PERSONNEL PRIOR TO DISTRIBUTION. THE DHRS OF THE COMPONENTS FOR TMJPM-2347 (B)(4)) WERE REVIEWED AND THERE WERE NO ANOMALIES FOUND. THE MOST LIKELY UNDERLYING CAUSE 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

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION IT WAS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCT: BIOMET MICROFIXATION SCREWS CATALOG #: NI LOT #: NI. REPORT SOURCE - FOREIGN COUNTRY: (B)(6). PMA/510(K) NUMBER: THIS PRODUCT IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS BIOMET MICROFIXATION MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER PMA NUMBER P020016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROSTHESES DID NOT FIT AS EXPECTED. DURING THE IMPLANT SURGERY, THE PRODUCT WAS IMPLANTED AS INTENDED, BUT THE OCCLUSION DID NOT FIT. THE SURGEON REMOVED THREE SCREWS AND REPOSITIONED THE MANDIBULAR COMPONENTS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428357 CUSTOM MADE DEVICE PM-TMJ & MODEL CUSTOM MADE TMJ LZD BIOMET MICROFIXATION N/A 875210A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention