BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE

    MDR report key: 12715818 · Received October 28, 2021

    Report

    Report Number
    0002023141-2021-03053
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    June 23, 2021
    Report Date
    November 16, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024015210
    PMA / PMN Number
    K011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT CORRECTED INFORMATION. ADDITIONAL INFORMATION FROM THE CUSTOMER REVEALS THAT THE EVENT DOES NO LONGER MEET THE REQUIREMENTS OF A REPORTABLE EVENT.

    Description of Event or Problem · 0

    WHEN INSTALLING THE ABUTMENT, THE ABUTMENT SCREW STRIPPED. THEY REMOVED THE ABUTMENT DESTRUCTIVELY. NEW ABUTMENT IS ALREADY INSTALLED.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT IDENTIFIER IS (B)(6). PATIENT WEIGHT IS NOT PROVIDED / UNKNOWN. INITIAL REPORTER¿S TITLE IS NOT PROVIDED / UNKNOWN. ADDITIONAL 510(K) NUMBERS ARE K013227 AND K953101.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT SCREW LOOSENED. TOOTH LOCATION # 36 (FDI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609222 ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE DENTAL ABUTMENT DZE ZIMMER DENTAL HLA4/5 2019050218 00889024015210

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male