BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN¿ TITANIUM HEXED SCREW

    MDR report key: 21853855 · Received April 17, 2025

    Report

    Report Number
    0001038806-2025-00815
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 19, 2025
    Report Date
    July 3, 2025
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008545
    PMA / PMN Number
    K072642
    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. E1: REPORTER NAME: 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. D4: ADDITIONAL DEVICE INFORMATION. D9: DEVICE AVAILABILITY. G3: DATE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H4: DEVICE MANUFACTURER DATE. H6: ADVERSE EVENT PROBLEM. H10: ADDITIONAL NARRATIVE. ZIMVIE RECEIVED ONE (1) IUNIHG, (CERTAIN GOLD-TITE TM HEXED SCREW) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED. FRACTURE IDENTIFIED AT HEAD OF THE SCREW. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER: 1213241. NO DEVIATIONS OR NON-CONFORMANCE'S, 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: 1213241 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 AT THE HEAD. THE REPORTED EVENT WAS CONFIRMED. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS 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 REPORTS THAT THE SCREW FRACTURED AT THE HEAD AND WAS REMOVED. TOOTH POSITION: 26.

    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
    113963 CERTAIN¿ TITANIUM HEXED SCREW DENTAL SCREW NHA BIOMET 3I 1213241 00844868008545

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female