BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT GOLD FRICTION-FIT 4. 5MM IMP

    MDR report key: 15907713 · Received December 2, 2022

    Report

    Report Number
    0002023141-2022-03001
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    May 18, 2018
    Report Date
    April 4, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024015234
    PMA / PMN Number
    K011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE (1) ABUT GOLD FRICTION-FIT 4. 5MM IMP (HLA4G) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED SIGNS OF USE BUT NO DAMAGE/MALFUNCTION. FUNCTIONAL TESTING WAS PERFORMED AND THE ABUTMENT ENGAGED/SEATED/RETAINED AS INTENDED WITH IN-HOUSE IMPLANT. NO PRE-EXISTING CONDITIONS WERE NOTED. THE DEVICE HAD BEEN PLACED ON TOOTH SITE #14 (UNKNOWN DENTAL NOTATION SYSTEM) FOR AN UNKNOWN PERIOD OF TIME. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 63764543. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 63764543 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FUNCTIONAL : LOOSENING THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PREMARKET IDENTIFICATION K013227 AND K953101.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DUE TO TOO LITTLE FRICTION WITH THE HEXAGON THE ABUTMENT CAME LOOSE. TOOTH SITE 14. PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403030 ABUT GOLD FRICTION-FIT 4. 5MM IMP DENTAL ABUTMENT DZE ZIMMER DENTAL HLA4G 63764543 00889024015234

    Patients

    Seq Age Sex Outcome Treatment
    1 Female