BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK¿ HYBRID BAR 6 IMPLANTS

    MDR report key: 15754302 · Received November 8, 2022

    Report

    Report Number
    0001038806-2022-01710
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Report Date
    February 24, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K080864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE BELLATEK HYBRID BAR 6 IMPLANTS, CSHY06 WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL INSPECTION COULD NOT BE PERFORMED AND THE INVESTIGATION WILL BE OF THE DHR, DESIGN FILES AND RISK MANAGEMENT FILES. PICTURE/X-RAY: PICTURES OR X-RAYS WERE NOT PROVIDED. APPROPRIATE DOCUMENTS WERE REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1170888). 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 WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. A LOT SPECIFIC COMPLAINT HISTORY REVIEW IS NOT CONDUCTED FOR PSP COMPLAINTS. PATIENT SPECIFIC PRODUCTS HAVE A UNIQUE ONE TIME USE LOT NUMBER. THEREFORE, A LOT SPECIFIC HISTORY SEARCH FOR THIS COMPLAINT IS NOT PERFORMED. DECEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (FRACTURE) OR PRODUCT (CSHY06). 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

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREW SEAT IS BROKEN ON #15. BAR WILL NOT BE RETURNING. BAR WILL NOT BE REMADE FROM 2014. CS REP REPORTED THAT THE CYLINDERS THAT ARE THE ISSUE. THE SCREWS NO LONGER ENGAGE. THE PATIENT DOES NOT WANT TO GIVE UP THE BAR TO THE DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2529720 BELLATEK¿ HYBRID BAR 6 IMPLANTS HYBRID BAR NHA BIOMET 3I 1170888

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose