BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLD-TITE® SQUARE UNISCREW

    MDR report key: 23776296 · Received December 11, 2025

    Report

    Report Number
    0001038806-2025-03746
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 27, 2025
    Report Date
    February 9, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    NHA
    UDI-DI
    00844868017325
    PMA / PMN Number
    K072642
    Adverse Event
    Yes
    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). A4: PATIENT WEIGHT: UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). ZIMVIE RECEIVED ONE (1) UNISG, (GOLD-TITE SQUARE UNISCREW), FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, A FRACTURE HAS BEEN IDENTIFIED AT THE THREADS. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1246019. 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 1246019 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. THE FRACTURE HAS BEEN IDENTIFIED AT THE THREADS. THE REPORTED EVENT IS 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

    IT WAS REPORTED THAT THE PATIENT LOST THE IMPLANT AT TOOTH SITE 34 DUE TO NON-INTEGRATION. ON 2021 GOLDTITE SCREW AT TOOTH SITE 35 FRACTURED AND THE SCREW WAS REMOVED. ON (B)(6) 2025 GOLDTITE SCREW AT TOOTH SITE 36 FRACTURED, BUT THIS TIME IT WAS IMPOSSIBLE TO REMOVE THE SCREW. DOCTOR DECIDED TO PUT TO SLEEP IMPLANT AT TOOTH SITE 36, AND A NEW IMPLANT WILL BE PLACED AT TOOTH SITE 34. IMPLANT AT TOOTH SITE 36 WAS PLACED ON (B)(6) 2009. THIS REPORT REFERS TO SCREW FRACTURE AT TOOTH SITE 36.

    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
    2732464 GOLD-TITE® SQUARE UNISCREW DENTAL SCREW NHA ZIMVIE US CORP LLC 1246019 00844868017325

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention