BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL INSTRUMENT

    MDR report key: 11824174 · Received May 14, 2021

    Report

    Report Number
    0001038806-2021-00805
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Report Date
    May 14, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    EJB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. DATE OF THE EVENT UNKNOWN / NOT PROVIDED. BRAND NAME UNKNOWN / NOT PROVIDED. DEVICE PRODUCT CODE UNKNOWN / NOT PROVIDED. ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. EMAIL ADDRESS WAS NOT PROVIDED. PREMARKET IDENTIFICATION PMA/510(K) NUMBER UNKNOWN / NOT PROVIDED. DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED. SINCE THE LOT NUMBER AND DEVICE WILL NOT BE RETURNED , IDENTIFYING A DEFINITIVE ROOT CAUSE WILL NOT BE POSSIBLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATED THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WOULD BE SUBMITTED.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT IMPLANT DISENGAGED FROM THE DRIVER AND FELL WHEN IT WAS GOING TO BE PLACED IN THE PATIENT'S MOUTH. ANOTHER IMPLANT WAS PLACED DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725763 DENTAL INSTRUMENT EJB BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1