BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE LARGE HEXED SCREW

    MDR report key: 22165929 · Received June 9, 2025

    Report

    Report Number
    0001038806-2025-01305
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    April 30, 2025
    Report Date
    August 21, 2025
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868006121
    PMA / PMN Number
    K972444
    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. 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. ZIMVIE RECEIVED ONE (1) ILRGHG, (CERTAIN GOLD-TITE LARGE HEXED SCREW) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED; THE SCREW WAS FRACTURED AT THE THREADS. THREADED PIECE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1232658. 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 1232658 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 PATIENT FACTORS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE SCREW WAS FRACTURED. 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A3: GENDER UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. D10. CONCOMITANT MEDICAL PRODUCTS ILRGHT, CERTAIN TITANIUM LARGE HEXED SCREW LOT 1281722. G4: PREMARKET IDENTIFICATION K072642.

    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 THE FRACTURES OF TWO SCREWS AT TOOTH SITE 36/37. CROWN MOBILITY DUE TO SCREW FRACTURE. IMPLANTS ARE STILL PLACED ON THE PATIENT. SCREWS PLACED ON (B)(6) 2020 AND REMOVED ON (B)(6) 2025. THE PROCESS WAS NOT COMPLETED. NO IMPACT ON THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355895 CERTAIN GOLD-TITE LARGE HEXED SCREW DENTAL SCREW DZE BIOMET 3I 1232658 00844868006121

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Unknown DENTAL SCREW SEE H10 NARRATIVE.