BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT GOLD FRICTION-FIT 4. 5MM IMP

    MDR report key: 12166937 · Received July 14, 2021

    Report

    Report Number
    0002023141-2021-01794
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    July 2, 2021
    Report Date
    July 26, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE ADDITIONAL INFORMATION IS THAT UPON FOLLOW UP WITH CUSTOMER IT WAS CONFIRMED THAT THE HEX OF THE ABUTMENT FRACTURED OFF. THE FOLLOWING SECTIONS ARE BEING REPORTED: B5: DESCRIBE EVENT OR PROBLEM. H2: TYPE OF FOLLOW UP. H6:DEVICE CODE(S) H10: NARRATIVE/DATA WAS UPDATED. UPON FOLLOW UP WITH CUSTOMER IT WAS CONFIRMED THAT THE HEX OF THE ABUTMENT FRACTURED OFF. THIS EVENT NO LONGER MEETS REPORTABILITY REQUIREMENTS. NO FURTHER MEDWATCH REPORTS WILL BE SUBMITTED FOR THIS EVENT.

    Description of Event or Problem · 0

    CUSTOMER CONFIRMED THAT THE HEX OF THE ABUTMENT FRACTURED OFF.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT AGE IS NOT PROVIDED / UNKNOWN. PATIENT WEIGHT IS NOT PROVIDED / UNKNOWN. LOT NUMBER IS NOT PROVIDED / UNKNOWN. INITIAL REPORTER¿S EMAIL ADDRESS IS NOT PROVIDED / UNKNOWN. ADDITIONAL 510(K) NUMBERS ARE K013227 AND K953101.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH BROKEN RESTORATION. UCLA ABUTMENT APPEARS TO HAVE STRUCTURAL DAMAGE. TOOTH SITE #13 (UNIVERSAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062434 ABUT GOLD FRICTION-FIT 4. 5MM IMP DENTAL ABUTMENT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1