BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3I T3 WITH DCD NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 10MM

    MDR report key: 19039022 · Received April 4, 2024

    Report

    Report Number
    0001038806-2024-00662
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    January 28, 2024
    Report Date
    August 7, 2024
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868029038
    PMA / PMN Number
    K122300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). ZIMVIE RECEIVED ONE (1) BNSS410, (3I T3® WITH DCD® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 10MM) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE, APPARENT BONE / TISSUE ATTACHED TO EXTERNAL THREADS. THE IMPLANT WAS IDENTIFIED AS REPORTED HOWEVER, NO APPARENT MALFUNCTION WAS IDENTIFIED WITH THE IMPLANT THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. IMPLANT MATCHED PRINTS WHERE MEASURED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2023011081. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 2023011081 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: MEDICAL OTHER THE CUSTOMER DID SUBMIT TEN (10) X-RAY IMAGES FOR THE REPORTED EVENT. IFU REVIEW: DOCUMENTS REVIEWED: BIOMET 3I DENTAL IMPLANT IFU P-IIS086GI REV. J 2022/08. INFORMATION IDENTIFIED: WARNINGS, CONTRAINDICATIONS,PRECAUTIONS. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE INADEQUATE TREATMENT PLANNING, PATIENT FACTORS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID NOT OCCUR. THE REPORTED EVENT WAS NON-VERIFIABLE 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. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Description of Event or Problem · 0

    2 IMPLANTS PLACED AT SITES #13 & #14, SITE #14 HAD A SINUS LIFT, GRAFTED WITH BONE GRAFT + PNF/PNPC ON IMPLANT PLACEMENT DATE. PT IS A SMOKER AND HAD RECURRENT SINUS INFECTIONS AND FACIAL SWELLING. IMPLANT WAS REMOVED AND SINUS DRAINED. NEW INFECTION ON EMT CONSULTATION - IMPLANT #13 WAS REMOVED SYMPTOMS AS A RESULT OF THE EVENT: PAIN. EDEMA. INFLAMMATION. ABSCESS.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2266983 3I T3 WITH DCD NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 10MM DENTAL IMPLANT DZE BIOMET 3I 2023011081 00844868029038

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention