BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM MADE DEVICE PROOT PM-TMJ & MODEL

    MDR report key: 8179097 · Received December 19, 2018

    Report

    Report Number
    0001032347-2018-00879
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    November 5, 2018
    Report Date
    May 24, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DESIGN VENDOR, 3D SYSTEMS, CONDUCTED AN INVESTIGATION INTO THE COMPLAINT. THEY STATE IN THE INVESTIGATION PORTION OF THE REPORT: REVIEW OF THE DIGITAL FILES VERIFY COMPONENTS WERE DESIGNED TO 470-500 TMJ COMPONENT DESIGN REQUIREMENTS. NO MISSING MATERIAL WAS IDENTIFIED IN THE RIGHT FOSSA DESIGN OR PARASOLID FILES PROVIDED TO ZIMMER BIOMET FOR TMJPM-2262. MODELS, GUIDES, AND IMPLANT SAMPLES WERE VISUALLY INSPECTED AND A FIT CHECK OF COMPONENTS WAS COMPLETED BY TRAINED TMJ AND QUALITY PERSONNEL PRIOR TO RELEASE PER 470-503 TMJP-PMI FINAL MODEL INSPECTION. THE DESIGN VENDOR REVIEW OF ALL DIGITAL FILES VERIFY COMPONENTS WERE DESIGNED TO 470-500 TMJ COMPONENT DESIGN REQUIREMENTS. NO PRODUCT WAS RETURNED AS THE IMPLANTS REMAIN IMPLANTED; THEREFORE NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. NO POST-OPERATIVE SCANS, X-RAYS, PICTURES, OR PHYSICIANS REPORTS WERE PROVIDED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). CONCOMITANT MEDICAL DEVICE: BIOMET MICROFIXATION UNKNOWN SCREWS, CATALOG #: NI, LOT #: NI THERAPY DATE: (B)(6) 2018. 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. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 MATERIAL WAS MISSING FROM THE LATERAL INFERIOR EDGE OF FOSSA COMPONENT AND THE SURGEON HAD DIFFICULTY PLACING THE COMPONENTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017064 CUSTOM MADE DEVICE PROOT PM-TMJ & MODEL CUSTOM MADE TMJ LZD BIOMET MICROFIXATION N/A 865310A

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR