BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZFX, GENTEK TIBASE, TSV/TM ENGAGING, 3.5MMD X 4.7MMH

    MDR report key: 21959813 · Received May 5, 2025

    Report

    Report Number
    3008932779-2025-00011
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    March 16, 2025
    Report Date
    June 11, 2025
    Manufacturer
    ZFX GMBH
    Product Code
    NHA
    UDI-DI
    04251881713824
    PMA / PMN Number
    K231915
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. D4: ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. D9: DEVICE AVAILABILITY UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). ZIMVIE DID NOT RECEIVE ONE (1) ZFX-ZB-TSV-3547-EL FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER AND RISK MANAGEMENT FILE. ON (B)(6) 2023 WE TESTED THE LOT 0000231019 AT INCOMING INSPECTION. NO ERRORS WAS FOUND. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 0000231018 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: SCREW FRACTURE. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED A FRACTURE OF THE INDEXED HEXAGONAL PART OF THE TI-BASE AT TOOTH SITE 36 INSIDE THE IMPLANT, LEAVING THE IMPLANT SEPARATED FROM THE CROWN. IT WAS IMPOSSIBLE TO REPLACE THE CROWN AND THE IMPLANT WAS REMOVED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820932 ZFX, GENTEK TIBASE, TSV/TM ENGAGING, 3.5MMD X 4.7MMH DENTAL SCREW NHA ZFX GMBH 0000231018 04251881713824

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention