BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM MADE DEVICE SIBOSHVILI PM-TMJ & MODEL

    MDR report key: 8420351 · Received March 14, 2019

    Report

    Report Number
    0001032347-2019-00167
    Event Type
    Injury
    Date Received
    March 14, 2019
    Report Date
    July 17, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    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 SUPPORTS THE REVISION WAS PERFORMED. IT WAS REPORTED THAT THE REASON FOR THE REVISION WAS DUE TO INFECTION. THREE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION AND POTENTIAL PRODUCT RETURN. NO ADDITIONAL INFORMATION X-RAYS, SCANS, PICTURES OR PHYSICIANS REPORTS WERE PROVIDED. NO PRODUCT WAS RETURNED AND NO TESTS OR INSPECTIONS COULD BE PERFORMED. THE DHR AND STERILE CERTIFICATES WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT REPORTED EVENT WAS DUE TO PATIENT CONDITION. THERE WAS NO EVIDENCE TO INDICATE THAT THE INFECTION WAS IMPLANT RELATED OR 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. THE FOLLOWING FIELDS WERE UPDATED: DATE OF THIS REPORT, DESCRIBE EVENT OR PROBLEM, DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT, FOLLOW UP TYPE, DEVICE EVALUATED BY MANUFACTURER, METHOD CODE, RESULTS CODE, CONCLUSIONS CODE AND, ADDITIONAL NARRATIVES/DATA.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICE: BIOMET MICROFIXATION UNKNOWN TMJ SCREWS, CATALOG #: NI, LOT #: NI. THERAPY DATE: UNKNOWN. 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 U.S. 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 A REVISION OF THE RIGHT SIDE WAS PERFORMED DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215599 CUSTOM MADE DEVICE SIBOSHVILI PM-TMJ & MODEL CUSTOM MADE TMJ LZD BIOMET MICROFIXATION N/A 819980A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R