BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSX IMPLANT, 5.4MMD, 11.5MML

    MDR report key: 19512231 · Received June 11, 2024

    Report

    Report Number
    0001038806-2024-01224
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    May 20, 2024
    Report Date
    October 30, 2024
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868045229
    PMA / PMN Number
    K220978
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A4: WEIGHT UNKNOWN/NOT PROVIDED. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: TYPE OF INVESTIGATION CODES WERE ADDED: 4109, 4111 AND 3331. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 67. H10: NARRATIVE/DATA WAS UPDATED. ZIMVIE RECEIVED THE REPORTED IMPLANT FOR EVALUATION. VISUAL EVALUATION / FUNCTIONAL TEST WAS PERFORMED, SLIGHT WEAR HOWEVER NO DAMAGE TO THE IMPLANT WAS IDENTIFIED THAT WOULD CAUSE OR CONTRIBUTE TO THE EVENT. MARKINGS DUE TO THE REMOVAL PROCESS. 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 OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS INADEQUATE TREATMENT PLANNING. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR. SLIGHT WEAR HOWEVER NO DAMAGE TO THE IMPLANT WAS IDENTIFIED THAT WOULD CAUSE OR CONTRIBUTE TO THE EVENT. 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 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

    IT WAS REPORTED THAT THE THREADS WERE EXPOSED ON THE IMPLANT AT TOOTH LOCATION # 18 AND THE SITE HAD A PERIODONTAL DEFECT DISTAL TO THE IMPLANT THAT NEVER HEALED PROPERLY. THE IMPLANT WAS REMOVED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523578 TSX IMPLANT, 5.4MMD, 11.5MML DENTAL IMPLANT DZE BIOMET 3I 1260235 00844868045229

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention