BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 6M M 5.7MM 8MM

    MDR report key: 21504854 · Received March 3, 2025

    Report

    Report Number
    0002023141-2025-00528
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    April 22, 2024
    Report Date
    May 31, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019416
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER: (B)(4). ZIMVIE RECEIVED ONE (1) TSV6B8, (IMPL TAPERED SCR-V SBM 6M M 5.7MM 8MM) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, THE IMPLANT HAD SIGNS OF USE/WEAR WITH BONE DEBRIS ON THE EXTERNAL THREADS. NO DAMAGE IDENTIFIED OR SIGNS OF MALFUNCTION THAT WOULD HAVE CONTRIBUTED TO THE EVENT. MEASUREMENTS MATCH. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1250614. 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 1250614 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL: MEDICAL: ALLERGIC REACTION. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS CUSTOMER ERROR OR PATIENT FACTORS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID NOT OCCUR. NO DAMAGE TO THE IMPLANT WAS IDENTIFIED. THE REPORTED EVENT WAS NON-VERIFIABLE. 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. 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT: UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION: K011028/K013227.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT ON TOOTH LOCATION 27 WAS REMOVED DUE TO ALLERGIC REACTION. PAIN REPORTED AS A CONSEQUENCE OF THE EVENT. PATIENT WILL RETURN TO COMPLETE THE PROCEDURE. BONE TYPE III.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146974 IMPL TAPERED SCR-V SBM 6M M 5.7MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL 1250614 00889024019416

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention