BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL ABUTMENT

    MDR report key: 18624012 · Received February 1, 2024

    Report

    Report Number
    0001038806-2024-00159
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Report Date
    January 31, 2024
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ZIMVIE RECEIVED ONE (1) UNKNOWN ZIMMER ABUTMENT FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, HEX OF THE ABUTMENT HEX WAS FOUND FRACTURED INSIDE THE RETURNED IMPLANT. DHR, STERILIZATION, AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE SUBJECT LOT NUMBER ASSOCIATED WITH THE [UNKNOWN BIOMET ABUTMENT] IS NOT AVAILABLE. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO PREVENT THE DISTRIBUTION OF NON-CONFORMING PRODUCT AND ENSURE THE PRODUCT IS WITHIN SPECIFICATIONS. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS MATERIAL SELECTION OF THE PRODUCT IS NOT ADEQUATE TO WITHSTAND OCCLUSAL FORCES THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR. THE ABUTMENT HEX WAS FOUND FRACTURED INSIDE THE RETURNED IMPLANT . THE EVENT WAS CONFIRMED. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Description of Event or Problem · 0

    UPON REVIEW/INSPECTION OF RETURNED PRODUCT. A FRACTURED FRAGMENT (UNKNOWN ABUTMENT/MOUNT WAS IDENTIFIED INSIDE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260495 DENTAL ABUTMENT NHA BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female