BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTEK SCANBODY, CERTAIN, 4.1MMD

    MDR report key: 23264535 · Received October 10, 2025

    Report

    Report Number
    3008932779-2025-00038
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Report Date
    December 8, 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. B3: DATE OF EVENT: 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). ZFX RECEIVED ONE (1) ITEM GENTEK® SCANBODY, CERTAIN®, 4.1MMD, FOR EVALUATION. VISUAL EVALUATION / FUNCTIONAL TEST WAS PERFORMED: VISUAL EVALUATION: SCANBODY-TI-PART HAS NO DAMAGES, PEEK IS SITTING IN RIGHT POSITION. THE SCREW IS BROKEN. BROKEN THREAD IS NOT SEND TO ZFX. FUNCTIONAL TEST: ASSEMBLY TEST WITH IMPLANT WAS PERFORMED. SCREW WITH DRAWING S080.04 IS BROKEN, INNER HEX IS WORKING. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER: 2409110001 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL: FUNCTIONAL: FRACTURE: SCREW¿ 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 OCCUR. SCREW HOLDS TORQUES OVER 45 NCM. THE SCREW SHOULD ONLY BE TIGHTENED ENOUGH FOR THE SCAN BODY TO SIT IN PLACE. THE SPECIFIC VALUES FOR THIS ARE AROUND 15 NCM. PART IS IN UNUSABLE CONDITION. SCREW IS BROKEN. THE REPORTED EVENT WAS 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 INTERNAL SCREW OF THE SCANBODY FRACTURED. PROCEDURE WAS COMPLETED.

    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
    341959 GENTEK SCANBODY, CERTAIN, 4.1MMD DENTAL SCANBODY NDP ZFX GMBH 2409110001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown