BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK ABUTMENT TSV 4.5MM

    MDR report key: 10765545 · Received October 30, 2020

    Report

    Report Number
    0001038806-2020-01697
    Event Type
    Malfunction
    Date Received
    October 30, 2020
    Report Date
    February 8, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K071439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE DEVICE INVESTIGATION CONFIRMED THAT MHLAS ABUTMENT SCREW WILL NEED TO FILE SEPARATE FROM THE BELLATEK ABUTMENT (TSVLDAT4). UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS LOOSENING EVENT WAS FILED UNDER THE INCORRECT DEVICE (TSVLDAT4) AND THEREFORE, INCORRECT MANUFACTURING SITE, MFR NUMBER (0001038806-2020-01697) ON 30 OCT 2020. AS A RESULT, THE EVENT HAS BEEN REASSESSED AND IS BEING FILED UNDER THE CORRECT MFR NUMBER (0002023141 - 2021 - 00344). AS A RESULT, NO FURTHER MEDWATCH REPORTS WILL BE SUBMITTED FOR TSVLDAT4. PLEASE REFER TO MFR# 0002023141 - 2021 - 00344 FOR FOLLOW UP SUBMISSIONS AND INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE DEVICE INVESTIGATION CONFIRMED THAT MHLAS ABUTMENT SCREW WILL NEED TO FILE SEPARATE FROM THE BELLATEK ABUTMENT (TSVLDAT4). THE ABUTMENT WOULD NOT HAVE LOOSENED WITHOUT THE ABUTMENT SCREW AS THE SCREW ATTACH THE ABUTMENT IN PLACE. SEE H10 FOR DETAILS.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT WEIGHT: NOT PROVIDED. EVENT DATE: NOT PROVIDED. INITIAL REPORTER FAX NUMBER: NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER: K143505.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BELLATEK ABUTMENT (TSVLDAT4) AND CROWN CAME LOOSE CONTINUALLY IN THE PATIENT'S MOUTH. ATTEMPTED ABUTMENT PLACEMENT INTO A DIFFERENT IMPLANT AND THERE WAS NO FRICTION FIT ENGAGING. NO INJURY TO THE PATIENT NOTED. PATIENT WILL RETURN FOR A NEW PROSTHESIS. TOOTH #19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226906 BELLATEK ABUTMENT TSV 4.5MM PSP ABUTMENT NHA BIOMET 3I 8518272-1

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR