BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

    MDR report key: 18757693 · Received February 22, 2024

    Report

    Report Number
    0002023141-2024-00425
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    October 25, 2023
    Report Date
    August 21, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019522
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). ZIMVIE RECEIVED ONE (1) TSVB13, (IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, THE IMPLANT HAD SIGNS OF USE. THE IMPLANT WAS FRACTURED AT THE COLLAR. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1250588. 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 1250588 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL : FUNCTIONAL : FRACTURE : IMPLANT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS THE CLINICIAN SELECTS IMPLANT THAT IS UNABLE TO RESIST LONG-TERM OCCLUSAL LOADING. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE IMPLANT WAS FRACTURED AT THE COLLAR. 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). 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 IMPLANT MOBILITY AT TOOTH SITE #47. AFTER X-RAY IT IS APPRECIATED THE IMPLANT FRACTURED AND IT WAS REMOVED. BONE TYPE II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64857 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL 1250588 00889024019522

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female