BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET MICROFIXATION FACIAL PLATING SYSTEM

    MDR report key: 12330394 · Received August 17, 2021

    Report

    Report Number
    0001032347-2021-00400
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    June 9, 2021
    Report Date
    January 27, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    K121589
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2022-00029, 0001032347-2022-00030, 0001032347-2021-0000396, 0001032347-2022-00031, 0001032347-2022-00032, 0001032347-2022-00033, 0001032347-2022-00034. D10 ¿ MEDICAL PRODUCTS: ITEM # 91-6105, LOT # 863840 BIOMET MICROFIXATION FACIAL PLATING SYSTEM QTY 2; ITEM # 91-6105, LOT # 863840 BIOMET MICROFIXATION FACIAL PLATING SYSTEM QTY 4. ITEM RETURNED FOR INVESTIGATION. RETURNED SCREW CLEARLY FRACTURED AT THE SHAFT, NEAR THE HEAD OF THE SCREW. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT 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

    IT WAS REPORTED THAT THE SCREWS FRAGMENTED DURING IMPLANTATION. THE SURGEON REMOVED THE FRACTURED SCREWS DURING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). REPORT SOURCE: FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00396.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREWS FRAGMENTED DURING IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229798 BIOMET MICROFIXATION FACIAL PLATING SYSTEM PLATE, BONE JEY BIOMET MICROFIXATION N/A 863840

    Patients

    Seq Age Sex Outcome Treatment
    1 Female SEE H10