BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANA SPLAY PLUS

    MDR report key: 19582745 · Received June 20, 2024

    Report

    Report Number
    MW5156400
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Report Date
    June 20, 2024
    Manufacturer
    BIOMET 3I LLC
    Product Code
    EFB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    STERILE PROCESSING HAD LIMITED INFO IN WHICH TO PROCESS THE BIOMET PANA SPLAY. BIOMET KNOWS BETTER THAN TO RELEASE SOMETHING THIS INCOMPLETE. IF FDA DOESN'T CATCH THIS MAY BE SPD PROFESSIONALS NEED TO BE PART OF REVIEW PANEL. REAL SPD PROFESSIONALS NEED TO BE PART OF REVIEW PANEL. REAL SPD PEOPLE THAT DO THIS JOB NOT PODCAST PEOPLE WHO HAVEN'T PUSH A BUTTON ON STERILIZER IN OVER 10 YEARS. THANK YOU. REF REPORT: MW5156400. REF REPORT: MW5156399.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604590 PANA SPLAY PLUS HANDPIECE, AIR-POWERED, DENTAL EFB BIOMET 3I LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown