BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN¿ TITANIUM HEXED SCREW

    MDR report key: 17832286 · Received September 28, 2023

    Report

    Report Number
    0001038806-2023-01874
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    October 19, 2022
    Report Date
    February 26, 2024
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ZIMVIE RECEIVED ONE (1) IUNIHT, (CERTAIN TITANIUM HEXED SCREW) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, THE SCREW WAS FRACTURED AT THE THREADS. ONE (1) ESTB51T ¿ LOT 138175 WAS RETURNED FOR EVALUATION. NO FAILURES WERE IDENTIFIED. IT WAS RECORDED IN THE CONCOMITANT MEDICAL PRODUCT SECTION. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1063254. 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 1063254 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 THE MATERIAL SELECTION OF THE PRODUCT IS NOT ADEQUATE TO WITHSTAND OCCLUSAL FORCES. 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

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. D4: ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. H4: DEVICE MANUFACTURER DATE 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

    THE DOCTOR REPORTS THAT DURING A CHECK-UP, MOBILITY OF THE CROWN AT TOOTH LOCATION #35 WAS NOTED DUE TO SCREW BREAKAGE. THE SCREW WAS REMOVED AND THE PROCEDURE WAS CONCLUDED APPROPRIATELY BY PLACING ANOTHER PIECE WITHOUT ANY NEGATIVE IMPACT ON THE PATIENT'S HEALTH. SITE PRESENTED EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340566 CERTAIN¿ TITANIUM HEXED SCREW DENTAL SCREW NHA BIOMET 3I 1063254

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male