BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK ABUTMENT TSV 4.5MM

    MDR report key: 11286560 · Received February 5, 2021

    Report

    Report Number
    0002023141-2021-00307
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Report Date
    February 23, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NHA
    PMA / PMN Number
    K071439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION FOR THE INITIAL REPORT 0002023141-2021-00307. BASED ON ADDITIONAL INFORMATION, THIS EVENT IS NOT REPORTABLE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THAT THE ABUTMENT NEVER LOOSENED.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER ¿ K143505. LAST/GIVEN NAME UNKNOWN / NOT PROVIDED. DEVICE LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT LOOSENED IN THE PATIENTS MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183912 BELLATEK ABUTMENT TSV 4.5MM DENTAL ABUTMENT NHA ZIMMER DENTAL 8603910-1

    Patients

    Seq Age Sex Outcome Treatment
    1