BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT GOLD FRICTION-FIT 4. 5MM IMP

    MDR report key: 15904044 · Received December 2, 2022

    Report

    Report Number
    0002023141-2022-02996
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    February 11, 2019
    Report Date
    March 29, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    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 AND SCREW. NO PRE-EXISTING CONDITIONS WERE NOTED. THE DEVICE HAD BEEN PLACED ON TOOTH SITE #25 (UNKNOWN DENTAL NOTATION SYSTEM) FOR AN UNKNOWN PERIOD OF TIME. DHR REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBERS ASSOCIATED TO THE ITEMS WERE NOT PROVIDED. HOWEVER, ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE HLA4G DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT FOR SIMILAR EVENT. 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

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. LOT NUMBER UNKNOWN / NOT PROVIDED. UDI NOT AVAILABLE. LAST NAME UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER: 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

    DOCTOR REPORTED THAT ABUTMENT LOOSENED. PLACED ON (B)(6) 2018. PATIENT'S CONDITION WAS GOOD. PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396447 ABUT GOLD FRICTION-FIT 4. 5MM IMP DENTAL ABUTMENT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Male