BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTEK SCANBODY, CERTAIN, 4.1MMD

    MDR report key: 23513844 · Received November 10, 2025

    Report

    Report Number
    0001038806-2025-03058
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    September 16, 2025
    Report Date
    December 16, 2025
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 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-TI-PART HAS NO DAMAGES, PEEK IS SITTING IN RIGHT POSITION. THE SCREW IS BROKEN. BROKEN THREAD IS SEND TO ZFX. -FUNCTIONAL TEST: ASSEMBLY TEST WITH IMPLANT WAS PERFORMED. SCREW IS BROKEN, INNER HEX IS WORKING. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 2408260002 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 SCANBODY WAS TIGHTEN WITH MORE THAN 15 NCM, WHICH IS THE MAXIMUM TORQUE STATED ON THE IFU. 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 WHEN ATTEMPTING TO UNSCREW THE SCANBODY, IT BROKE AT THE SCREW AREA, AND NOW THE ITEM DOES NOT FUNCTION PROPERLY WHEN SCREWING AND UNSCREWING. IT WAS NOTICED UPON FIRST USE. PRODUCT WAS REMOVED AND PROCEDURE 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
    1962717 GENTEK SCANBODY, CERTAIN, 4.1MMD DENTAL SCANBODY NDP ZIMVIE US CORP LLC 2408260002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown