BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN TITANIUM HEXED SCREW

    MDR report key: 11841861 · Received May 18, 2021

    Report

    Report Number
    0001038806-2021-00851
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Report Date
    August 27, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008545
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) CERTAIN® TITANIUM HEXED SCREW (IUNIHT) WAS NOT RETURNED FOR INVESTIGATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM AND LOT NUMBER ALONG WITH THE APPLICABLE DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND RISK FILE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. NO PRE-EXISTING CONDITIONS WERE REPORTED AND NO PER FORM WAS PROVIDED. THE REPORTED DEVICE WAS LOCATED ON TOOTH # 19 (UNIVERSAL) AND WAS USED FOR AN UNKNOWN AMOUNT OF TIME. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1243466). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1243466) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT G3: DATE RECEIVED BY MANUFACTURER G6: CHECKED "FOLLOW-UP" H2: CHECKED FOLLOW-UP TYPE H3: CHANGED "YES" TO "NO" H6: ENTERED EVALUATION CODES H10: ADDED MANUFACTURER NARRATIVE H3 OTHER TEXT : DEVICE NOT RETURNED

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REPLACEMENT SCREW THEY RECEIVED FROM A PREVIOUS COMPLAINT FRACTURED IN THE PATIENTS MOUTH AFTER A FEW DAYS. TOOTH #19. CLINICIAN WAS UNABLE TO RETRIEVE THE BROKEN PORTION FROM THE IMPLANT SO HE REFERRED THE PATIENT TO AN ORAL SURGEON FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737138 CERTAIN TITANIUM HEXED SCREW DENTAL SCREW NHA BIOMET 3I IUNIHT 1243466 00844868008545

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention