BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK ABUTMENT TSV 4.5MM

    MDR report key: 10762945 · Received October 30, 2020

    Report

    Report Number
    0001038806-2020-01694
    Event Type
    Malfunction
    Date Received
    October 30, 2020
    Report Date
    February 11, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868038092
    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 FILED SEPARATELY 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 -01694) ON 30 OCT 2020. AS A RESULT, THE EVENT HAS BEEN REASSESSED AND IS BEING FILED UNDER THE CORRECT MFR NUMBER (0002023141-2021 -00357). AS A RESULT, NO FURTHER MEDWATCH REPORTS WILL BE SUBMITTED FOR TSVLDAT4. PLEASE REFER TO MFR# 0002023141-2021-00357) FOR FOLLOW UP SUBMISSIONS AND INVESTIGATION RESULTS. SECTIONS UPDATED: B4: DATE OF THIS REPORT G4: DATE ADDITIONAL INFORMATION WAS RECEIVED BY MANUFACTURER. G7: TYPE OF REPORT AND FOLLOW UP NUMBER. H2: FOLLOW UP TYPE. H10 MANUFACTURER'S NARRATIVE.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). PATIENT'S WEIGHT IS UNKNOWN. EVENT DATE IS UNKNOWN. TITLE OF REPORT IS UNKNOWN. ADDITIONAL 510(K) NUMBER IS K143505. PRODUCT HAS NOT YET BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT AND CROWN CAME LOOSE 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
    1227535 BELLATEK ABUTMENT TSV 4.5MM ABUTMENT NHA BIOMET 3I TSVLDAT4 8518272-1 00844868038092

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR