BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN EP HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H)

    MDR report key: 11585850 · Received March 29, 2021

    Report

    Report Number
    0001038806-2021-00521
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    February 8, 2021
    Report Date
    July 14, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008392
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVALUATION: ONE CERTAIN® EP® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) (ITHA54) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THAT THE DEVICE WAS FRACTURED AT THE THREADED REGION. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE DEVICE WAS FRACTURED. PRE-EXISTING CONDITION NOTED ON THE PER WAS MODERATE BONE DENSITY ¿ TYPE II. THE REPORTED DEVICE WAS INTENDED FOR TOOTH # 30 (UNIVERSAL). REVIEW OF APPROPRIATE DOCUMENTATION: PER THE APPLICABLE IFU, IT IS STATED THAT IMPROPER TECHNIQUE CAN LEAD TO DEVICE FAILURE. ADDITIONALLY, BREAKAGE MAY OCCUR WHEN DEVICE IS LOADED BEYOND ITS FUNCTIONAL CAPABILITY. DHR REVIEW: DHR REVIEW FOR THE LOT (1240683) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1240683) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FRACTURE) AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TRENDING REVIEW: MAY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT FRACTURED AT 20 NCM TORQUE. THE REMAINING PORTION OF THE ABUTMENT WAS REMOVED AND A NEW PROVISIONAL ABUTMENT PLACED AND TORQUED WITHOUT A PROBLEM. TOOTH #30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483438 CERTAIN EP HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) ABUTMENT NHA BIOMET 3I ITHA54 1240683 00844868008392

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR