BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL SCREW

    MDR report key: 17560547 · Received August 16, 2023

    Report

    Report Number
    0001038806-2023-01569
    Event Type
    Injury
    Date Received
    August 16, 2023
    Date of Event
    January 21, 2023
    Report Date
    February 11, 2024
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: NANOTITE TM TAPERED CERTAIN IMPLANT 3.25 X 11.5MM, LOT NUMBER 833744 .

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION. ZIMVIE RECEIVED ONE PORTION OF THE UNKNOWN SCREW FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE FRACTURED SCREW INSIDE THE IMPLANT. SIGNS OF USE WERE NOTED ON THE IMPLANT, APPARENT BONE DEBRIS ON EXTERNAL THREADS. DAMAGE TO THE IMPLANT WAS IDENTIFIED, LIKELY FROM THE REMOVAL PROCESS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. DHR, STERILIZATION, AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE SUBJECT LOT NUMBER ASSOCIATED WITH THE UNKNOWN SCREW 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 CAUSES DETERMINED FROM THE INVESTIGATION ARE MISSING OR CONFUSING INSTRUCTIONS FOR USE, TORQUE APPLIED DURING PLACEMENT/ SEATING EXCEEDS RECOMMENDED VALUE, PATIENT FACTORS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE REPORTED EVENT WAS CONFIRMED WITH ALL THE AVAILABLE INFORMATION. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS 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

    PER INDICATED: FRACTURE SCREW IN IMPLANT, NOT RETRIEVABLE. IMPLANT TREPHINED OUT AND SITE GRAFTED.

    Description of Event or Problem · 0

    NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1982346 DENTAL SCREW NHA BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention DENTAL IMPLANT, SEE NARRATIVE H10