BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM MADE DEVICE DAY RIGHT PM-TMJ & MODEL

    MDR report key: 8317423 · Received February 7, 2019

    Report

    Report Number
    0001032347-2019-00101
    Event Type
    Injury
    Date Received
    February 7, 2019
    Date of Event
    January 16, 2019
    Report Date
    June 20, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    N/A
    Adverse Event
    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. REPORTED EVENT WAS CONFIRMED BY REVIEW OF EVIDENCE THAT THE REVISION WAS PERFORMED. IT WAS LATER REPORTED THAT THERE WAS "NO INFECTION SO FAR CONFIRMED FROM EITHER TISSUE OR FOSSA COMPONENT." THE SURGEON ALSO INDICATED HE "FOUND THAT THERE WAS A COMMUNICATING CHANNEL BETWEEN THE EAR CANAL AND THE TMJ AREA. PATIENT HAS REPEATEDLY SUFFERED FOR MANY YEARS FROM EAR INFECTIONS SO ISSUES WITH THE JOINT AREA MOST LIKELY DUE TO THIS." DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO PATIENT CONDITION. THERE WAS NOTHING TO INDICATE THAT THERE WAS AN ALLEGED MALFUNCTION OF THE IMPLANTS. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00191-1 & 0001032347-2019-00192-1.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. MEDICAL DEVICE: BIOMET MICROFIXATION SCREW CATALOG #: 99-6579 LOT #: NI, BIOMET MICROFIXATION SCREW CATALOG #: 99-6581 LOT #: NI. THERAPY DATE: (B)(6) 2019. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00191 & 0001032347-2019-00192.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE: BIOMET MICROFIXATION SCREWS, CATALOG #: NI, LOT #: NI. THERAPY DATE: (B)(6) 2019. 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. 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 AN EXPLORATORY SURGERY TO DETERMINE WHETHER THE PATIENT HAS DEVELOPED AN INFECTION WAS PERFORMED. NO INFECTION WAS CONFIRMED FROM EITHER TISSUE OR FOSSA COMPONENT. THE SURGEON FOUND THAT THERE WAS A COMMUNICATING CHANNEL BETWEEN THE EAR CANAL AND THE TMJ AREA. THE PATIENT HAS REPEATEDLY SUFFERED FOR MANY YEARS FROM EAR INFECTIONS SO ISSUES WITH THE JOINT AREA MOST LIKELY DUE TO THIS. THE FOSSA WAS REMOVED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108847 CUSTOM MADE DEVICE DAY RIGHT PM-TMJ & MODEL CUSTOM MADE TMJ LZD BIOMET MICROFIXATION N/A 703380A

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| R