BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM MADE DEVICE HANRATTY LEFT PM-TMJ & MODEL

    MDR report key: 8317432 · Received February 7, 2019

    Report

    Report Number
    0001032347-2019-00092
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DESIGN VENDOR STATED THE EXISTING METAL FOSSA (NON ZIMMER BIOMET DEVICE) ON THE PATIENT DID CAUSE SOME METAL SCATTER AND THE NEW FOSSA IMPLANT WAS DESIGNED AROUND THESE INCONSISTENCIES IN THE MAXILLA BONE. ALSO, WHEN THE EXISTING METAL FOSSA IMPLANT WAS REMOVED DURING SURGERY IT MAY HAVE POTENTIALLY ALTERED THE BONE THAT IS UNPREDICTABLE IN THE PLANNING PROCESS LEADING TO AN IMPROPER FIT

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE DIGITAL FILES. THE DESIGN VENDOR REVIEW OF ALL DIGITAL FILES VERIFY COMPONENTS WERE DESIGNED TO 470-500 TMJ COMPONENT DESIGN REQUIREMENTS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE DESIGN VENDOR DETERMINED THAT THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT IS DUE TO THE BONEY ANATOMY BEING MODIFIED DURING THE EXPLANTATION OF THE DEVICES IN PLACE AND THE FLOATING ARTIFACTS IN THE SURROUNDING AREA. THE COMPLAINT IS CONFIRMED AND THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT IS PATIENT CONDITION. 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

    ADDITIONAL INFORMATION WAS RECEIVED. IN REGARDS TO THE OUTCOME OF THE CASE, IT IS REPORTED THE PATIENT IS DOING WELL.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN COUNTRY: (B)(6). 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 THE IMPLANT DID NOT FIT PROPERLY WHEN BEING INSERTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111937 CUSTOM MADE DEVICE HANRATTY LEFT PM-TMJ & MODEL CUSTOM MADE TMJ LZD BIOMET MICROFIXATION N/A 857700

    Patients

    Seq Age Sex Outcome Treatment
    1