BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN¿ GOLD-TITE¿ HEXED SCREW

    MDR report key: 19960185 · Received August 12, 2024

    Report

    Report Number
    0001038806-2024-01743
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 15, 2024
    Report Date
    September 30, 2024
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008538
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. 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 HEXED SCREW) FOR EVALUATION. VISUAL EVALUATION AND A FUNCTIONAL TEST WAS PERFORMED, SIGNS OF USE WAS IDENTIFIED. THE THREADING HAS SOME DISCOLORATIONS. THE SCREW THREADED INTO IN-HOUSE IMPLANT AS INTENDED. UNABLE TO CONFIRM LOOSENING WITH ALL THE AVAILABLE INFORMATION. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1230668. 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 1230668 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL : FUNCTIONAL : LOOSENING. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS THE SCREW WASN¿T TORQUED TO SPECIFICATION. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE VERIFIED. THE SCREW THREADED INTO IN-HOUSE IMPLANT AS INTENDED. THE REPORTED LOOSENING EVENT WAS NON-VERIFIABLE WITH ALL THE AVAILABLE INFORMATION. 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). A4: PATIENT WEIGHT: UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    LOOSENING OF THE PROSTHETIC CROWN PLACED ON (B)(6) 2020 AND WAS REMOVED. PROCEDURE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725035 CERTAIN¿ GOLD-TITE¿ HEXED SCREW DENTAL SCREW NHA BIOMET 3I 1230668 00844868008538

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male