BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2G OTOMIMIX

    MDR report key: 18821597 · Received March 1, 2024

    Report

    Report Number
    0001032347-2024-00063
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    October 12, 2023
    Report Date
    June 28, 2024
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    NEA
    PMA / PMN Number
    K042516
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). D10 ¿ MEDICAL PRODUCTS ITEM # 7014-3266, LOT # 091260; 2G OTOMIMIX G3: FOREIGN SOURCE: FRANCE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2024-00064.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. 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. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B4, B5, G3, G6, H2, H3, H4, H6, AND H11.

    Description of Event or Problem · 0

    IT IS REPORTED THAT DURING THE PREPARATION OF THE OTOMIMIX DURING A TYMPANOPLASTY, IT WAS NOTICED THAT THE CEMENT DID NOT HAVE THE RIGHT CONSISTENCY. IT IS IMPOSSIBLE TO USE CEMENT BECAUSE IT IS TOO LIQUID LIKE. A SECOND BATCH OF CEMENT WAS PREPARED AND THAT ONE HAD THE SAME MALFUNCTION. IT WAS TOO LIQUID LIKE AND ONCE IT DRIED, IT CRUMBLED. AS A RESULT, THE PATIENT WAS UNABLE TO UNDERGO OSSICULOPLASTY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261380 2G OTOMIMIX CEMENT, EAR, NOSE AND THROAT NEA BIOMET MICROFIXATION N/A 091260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H10.