BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM

    MDR report key: 21250732 · Received January 28, 2025

    Report

    Report Number
    0002023141-2025-00230
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Report Date
    April 2, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020085
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). B3: DATE OF EVENT UNKNOWN / NOT PROVIDED. D9: DEVICE AVAILABILITY UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION K011028/K013227.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT, B5: DESCRIBE EVENT OR PROBLEM, D9: DEVICE AVAILABILITY, G3: DATE RECEIVED BY MANUFACTURER, G6: TYPE OF REPORT, H1: TYPE OF REPORTABLE EVENT, H2: FOLLOW UP TYPE, H3: DEVICE EVALUATED BY MANUFACTURER, H6: ADVERSE EVENT PROBLEM, H10: ADDITIONAL NARRATIVE. ZIMVIE RECEIVED ONE (1) TSVWB8, (IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED TO THE IMPLANT AND THERE WAS DAMAGE LIKELY FROM THE REMOVAL PROCESS. THE MOUNTS HEX WAS FRACTURED AND STUCK INSIDE THE IMPLANT. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1251406. 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 1251406 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL: FUNCTIONAL: DOES NOT DISENGAGE/RELEASE AND DENTAL: FUNCTIONAL: FRACTURE: MOUNT BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS THE CLINICIAN DIDN¿T FOLLOW RECOMMENDED PROTOCOL FOR IMPLANT PLACEMENT AND FINAL SEATING. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE MOUNT WAS FRACTURED AT THE HEX. THE REPORTED EVENT WAS CONFIRMED. 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.

    Description of Event or Problem · 0

    WHEN THE IMPLANT WAS PLACED, THE MOUNT REMAINED ATTACHED TO THE IMPLANT. AFTER SEVERAL ATTEMPTS, PART OF THE MOUNT FRACTURED INSIDE THE IMPLANT. IT WAS THEREFORE REMOVED AND REPLACED BY A LARGER IMPLANT.

    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
    1549237 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL 1251406 00889024020085

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female