BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN¿ EP¿ HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H)

    MDR report key: 15954788 · Received December 9, 2022

    Report

    Report Number
    0001038806-2022-01879
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    June 24, 2022
    Report Date
    March 23, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868006275
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ONE (1) CERTAIN EP HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) (IMHA34) 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 CONDITION NOTED, AND NO PER FORM WAS PROVIDED. BONE DENSITY TYPE IS UNKNOWN. THE REPORTED DEVICE WAS LOCATED ON AN UNKNOWN TOOTH SITE (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 (1241643). 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 (1241643) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (LOOSENING) OR PRODUCT (IMHA34). NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION AND THE REPORTED EVENT COULD NOT BE VERIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE ABUTMENT BECAME LOOSE AND DOCTOR TIGHTENED AND SENT PATIENT HOME. ABUTMENT WAS DISCARDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2842509 CERTAIN¿ EP¿ HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) DENTAL IMPLANT NHA BIOMET 3I IMHA34 1241643 00844868006275

    Patients

    Seq Age Sex Outcome Treatment
    1 Male