BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    MDR report key: 10228361 · Received July 3, 2020

    Report

    Report Number
    0002023141-2020-00999
    Event Type
    Injury
    Date Received
    July 3, 2020
    Date of Event
    June 4, 2020
    Report Date
    July 27, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM (TSVWB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED MINIMAL SIGNS OF WEAR AND DEBRIS ABOUT THE THREADS AND DRIVE FEATURE. IT IS INDICATED THAT THE PATIENT HAS A HISTORY OF BRUXISM AND CLENCHING. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 3 AND USED FOR APPROXIMATELY 6 MONTHS. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT (MEDICAL CONDITIONS). THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1230746. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1230746) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. MAY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (SINUS PERFORATION) OR PRODUCT (TSVWB10). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED AND THE REPORTED EVENT WAS NON-VERIFIABLE. A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE INVESTIGATION AND RISK FILE REVIEW, THE POTENTIAL CAUSES FOR THE REPORTED EVENT IS CLINICIAN ERROR IN CASE PLANNING.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT WEIGHT: NOT PROVIDED. ADDITIONAL PMA/ 510(K) NUMBER: K011028, K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT (TSVWB10) FAIL TO INTEGRATE, PERFORATED THE MAXILLARY SINUS AND LATER REMOVED. INFLAMMATION WAS ALSO REPORTED. TOOTH LOCATION 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691598 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 1230746

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention