BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSX IMPLANT, 5.4MMD, 11.5MML

    MDR report key: 18744882 · Received February 20, 2024

    Report

    Report Number
    0001038806-2024-00269
    Event Type
    Injury
    Date Received
    February 20, 2024
    Report Date
    July 17, 2024
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868045229
    PMA / PMN Number
    K220978
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED B3: DATE OF EVENT UNKNOWN / NOT PROVIDED E1: LAST NAME UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED, ONE (1) TSX54B11, (TSX¿ IMPLANT, 5.4MMD, 11.5MML) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED, THE IMPLANT WITH SIGNS OF USE. NO APPARENT MALFUNCTION WAS IDENTIFIED WITH THE IMPLANT. 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#: 1260235. 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#: 1260235. FOR SIMILAR EVENTS AND ONE (1) OTHER COMPLAINT WAS IDENTIFIED, ((B)(4)). REVIEW COMPLETED UTILIZING KEYWORDS: ¿MEDICAL OTHER¿. THE CUSTOMER, DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. IFU REVIEW: DOCUMENTS REVIEWED: BIOMET, 3I DENTAL IMPLANT IFU (P-TSXIMP), 2022/09 REV. A. INFORMATION IDENTIFIED: "WARNINGS" & "PRECAUTIONS" : BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, AS PER RMF RM-00053-HAZ, REV.12. THE MOST LIKELY, ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE MISSING OR CONFUSING INSTRUCTIONS FOR USE OR INADEQUATE TREATMENT PLANNING. 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H3: CHANGED "NO" TO "YES".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMPLANT AT SITE 19 WAS REMOVED DUE TO PATIENT STATING THEY WANTED IMPLANT DEEPER BECAUSE HE CLAIMED HE SAW METAL. NO FURTHER IMPACT TO PATIENT, SITE GRAFTED TOGETHER WITH IMPLANT PLACEMENT (DYNABLAST) (B)(6) 2023.

    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
    425686 TSX IMPLANT, 5.4MMD, 11.5MML DENTAL IMPLANT DZE BIOMET 3I 1260235 00844868045229

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Required Intervention