BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN¿ TITANIUM HEXED SCREW

    MDR report key: 15981499 · Received December 14, 2022

    Report

    Report Number
    0001038806-2022-01906
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    October 13, 2022
    Report Date
    April 10, 2023
    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

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE CERTAIN® TITANIUM HEXED SCREW, IUNIHT WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION VIA NAKED EYE AND CAMERA MAGNIFICATION DID NOT REVEAL A FRACTURE. SIGNS OF USE AT THE DRIVE FEATURE OBSERVED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE COMPLAINT. BONE DENSITY TYPE: TYPE III. THE REPORTED DEVICE WAS LOCATED AT TOOTH SITE #21 (FDI). DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1250153). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE'S, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. A LOT SPECIFIC COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE SUBJECT LOT NUMBER (1250153) DATING BACK 12 MONTHS FROM THE NOTIFICATION DATE, FOR SIMILAR EVENTS, USING COMPLAINT KEYWORDS : FRACTURE SCREW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCE'S/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS UNCONFIRMED FOLLOWING INSPECTION AND EVALUATION.

    Description of Event or Problem · 0

    DOCTOR REPORTED THAT PATIENT HAD CROWN MOBILITY. SCREW FRACTURE AT THE THREADS OF THE SCREW WAS DISCOVERED AND SCREW WAS REMOVED. TOOTH SITE 21.

    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
    475874 CERTAIN¿ TITANIUM HEXED SCREW DENTAL SCREW NHA BIOMET 3I IUNIHT 1250153 00844868008545

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male