BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23486005 · Received November 6, 2025

    Report

    Report Number
    0001038806-2025-02968
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    June 30, 2025
    Report Date
    December 23, 2025
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    NHA
    PMA / PMN Number
    K231915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 D8-9: DEVICE SERVICE AND AVAILABILITY 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 ZFX DID NOT RECEIVE ONE (1) SCREW, FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED BY THE ONE PICTURE SEND TO ZFX. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE RISK MANAGEMENT FILE. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RMF, THE EXACTLY ROOT CAUSE FROM BREAKING SCREW CAN NOT BE DETERMINED WITH THIS INFORMATION. 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).

    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 THE SCREW FRACTURED INSIDE THE IMPLANT AT TOOTH SITE 36 AND THE IMPLANT ALSO FRACTURED. BONE TYPE: II. THIS REPORT REFERS TO SCREW FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2688332 ZFX¿, GENTEK¿ TIBASE, TSV/TM ENGAGING, 3.5MMD X 4.7MMH DENTAL TIBASE NHA ZIMVIE US CORP LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Unknown