BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 21984624 · Received May 8, 2025

    Report

    Report Number
    3008932779-2025-00012
    Event Type
    Injury
    Date Received
    May 8, 2025
    Date of Event
    March 17, 2025
    Report Date
    August 28, 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. H4: DEVICE MANUFACTURER DATE: UNKNOWN / NOT PROVIDED. E1: REPORTER NAME: UNKNOWN / NOT PROVIDED.

    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 D4: ADDITIONAL DEVICE INFORMATION D9: DEVICE AVAILABILITY G3: DATE RECEIVED BY MANUFACTURER G6: TYPE OF REPORT H1: TYPE OF REPORTABLE EVENT H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER H4: DEVICE MANUFACTURER DATE H6: ADVERSE EVENT PROBLEM H10: ADDITIONAL NARRATIVE ZIMVIE DID RECEIVE ONE (1) ZFX-ZB-TSV-3547-EL FOR EVALUATION. ON THE BROKEN TI-BASE SEAT A CROWN. THE BROKEN HEX IS NOT SEND TO US. THE SCREW WAS SEND. VISUAL EVALUATION / FUNCTIONAL TEST WAS PERFORMED. THE HEX ON THE TI-BASE IS BROKEN. THE CROWN IS VERY OUT OF SYNC. THE CONIC CONTACT SURFACE FROM THE TI-BASE IS GRINDED AND LOST HIS ROUNDNESS. THE SCREW IS CONJUGATED, BUT NOT BROKEN. ON 27-10-2023 WE TESTED THE LOT 0000231019 AT IMCOMING INSPECTION. NO ERRORS WERE FOUND. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 0000231018. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR 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. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE VERIFIED. THE TI-BASE IS BROKEN, BUT DESTROYED BY GRINDING THE CONTACT SURFACE BY CUSTOMER. SHE CROWN IS VERY OUT OF SYNC AND THE PRINTING SURFACE IS DESTROYED BY GRINDING. THE WHOLE STRENGH IS BURDENED BY THE HEX. THE HEX IS NOT DESIGNET TO HOLD THE WHOLE STRENGH. DAMAGE IS INEVITABLE IN THIS CASE. WHEN THE HEX WAS BROKEN, BEND FROM THE SCREW IS LOGICAL CONCLUSON. THE REPORTED EVENT COULD NOT BE VERIFIED. 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

    DOCTOR REPORTED FRACTURE OF TIBASE HEX, WHICH REMAINED INSIDE THE IMPLANT AT TOOTH SITE 36. CROWN WAS UNSCREWED AND COULD NOT PLACED BACK AGAIN. IMPLANT HAD TO BE 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
    1120775 ZFX, GENTEK TIBASE, TSV/TM NON ENGAGING, 3.5MMD X 4.7MMH DENTAL TIBASE NHA ZFX GMBH 0000231018 04251881713824

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Required Intervention