BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTEK SCANBODY, CERTAIN, 4.1MMD

    MDR report key: 23264611 · Received October 10, 2025

    Report

    Report Number
    3008932779-2025-00039
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    April 8, 2025
    Report Date
    November 26, 2025
    Manufacturer
    ZFX GMBH
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    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). A1: PATIENT IDENTIFIER: UNKNOWN / NOT PROVIDED. A2: AGE AT TIME OF THE EVENT: UNKNOWN / NOT PROVIDED. A3: GENDER: UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT: UNKNOWN / NOT PROVIDED. D4: ADDITIONAL DEVICE INFORMATION: UNKNOWN / NOT PROVIDED. H4: DEVICE MANUFACTURER DATE: 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. D3: EMAIL ADRESS. G1: CONTACT OFFICE - FIRST/GIVEN NAME, LAST NAME AND EMAIL ADDRESS. G1: CONTACT OFFICE - MANUFACTURER SITE - EMAIL ADDRESS. 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 RECEIVED ONE (1) ITEM GENTEK® SCANBODY, CERTAIN®, 4.1MMD, FOR EVALUATION. VISUAL EVALUATION / FUNCTIONAL TEST WAS PERFORMED: -VISUAL EVALUATION: SCANBODY HAS NO DAMAGES, PEEK IS SITTING IN RIGHT POSITION. SCREW HAS CEMENT ON THREAD. NO PART FROM SCREW BROKEN. -FUNCTIONAL TEST: AFTER CLEANING THREAD, GAUGE WORKS. DIMENTIONS FROM DRAWING WERE MEASURED BY MICROMETER AND INDICATOR. ASSEMBLY TEST WITH IMPLANT WAS PERFORMED. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS TORQUE APPLIED DURING PLACEMENT/SEATING EXCEEDS RECOMMENDED VALUE THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID NOT OCCUR. PART IS IN USABLE CONDITION. SCREW IS NOT BROKEN. THE REPORTED EVENT WAS NOT CONFIRMED. 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

    THE DOCTOR REPORTED THAT THE SCANBODY'S SCREW FRACTURED INSIDE THE IMPLANT. IMPLANT REMAINS IMPLANTED.

    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
    341961 GENTEK SCANBODY, CERTAIN, 4.1MMD DENTAL SCANBODY NDP ZFX GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown