BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT GOLD FRICTION-FIT 3. 5MM IMP

    MDR report key: 22324237 · Received June 24, 2025

    Report

    Report Number
    0002023141-2025-01696
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    January 4, 2021
    Report Date
    September 3, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER: (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. G3: DATE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: ADVERSE EVENT PROBLEM. H10: ADDITIONAL NARRATIVE. ZIMVIE DID NOT RECEIVE ONE (1) HLA3G, (ABUT GOLD FRICTION-FIT 3. 5MM IMP) FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER, DEVICE HISTORY RECORD (DHR) REVIEW, AND RISK MANAGEMENT FILE (RMF). DEVICE HISTORY RECORD (DHR) REVIEW BY LOT NUMBER COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. 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 HLA3G DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/PRODUCT HOLDS FOR THE REPORTED PRODUCT FOR SIMILAR EVENT. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL : FUNCTIONAL : LOOSENING BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS CUSTOMER ERROR - ABUTMENT SCREW WAS NOT TORQUED TO SPECIFICATION. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION WAS NOT ESTABLISHED. WITHOUT DEVICE RECEIPT, THE REPORTED EVENT IS NON-VERIFIABLE. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: PREMARKET IDENTIFICATION K011028/K013227/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 MONOBLOCK CROWN WAS SCREWED AT TOOTH SITE 46 ON (B)(6) 2017. IT WAS LOOSE ON (B)(6) 2021 AND ON (B)(6) 2023 AND RETIGHTENED EACH TIME AGAIN. MONOBLOCK CROWN WAS REMOVED SOMEWHERE ELSE DUE TO LOOSENING. IN THEIR OWN CLINIC DOCTOR NOTICED A CRACK AT THE HEXA-ABUTMENT JUNCTION. ANOTHER IMPLANT CROWN WILL BE MANUFACTURED AT TOOTH SITE 46.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997536 ABUT GOLD FRICTION-FIT 3. 5MM IMP DENTAL ABUTMENT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown