BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 13029159 · Received December 17, 2021

    Report

    Report Number
    0002023141-2021-03655
    Event Type
    Injury
    Date Received
    December 17, 2021
    Report Date
    May 17, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PMA/510K: K011028, K013227.

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM, TSVWB10 WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE PRODUCT CONFIRMED FRACTURED SCREW PORTION OF UNKNOWN ZEST LOCATOR ABUTMENT (MANUFACTURED BY: ZEST ANCHORS INC- SUPPLIER ID: 4905-13795) IDENTIFIED WITHIN THE IMPLANT. DAMAGE OBSERVED TO THE IMPLANT LIKELY DUE TO REMOVAL PROCESS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. PRE-EXISTING CONDITIONS NOTED ON THE COMPLAINT: CLENCHING. BONE DENSITY TYPE IS III. THE REPORTED DEVICE WAS LOCATED ON TOOTH SITE 13 (UNIVERSAL) WHEN THE EVENT OCCURRED. DEVICE WAS IN USE FOR 7 YEARS. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (60815161). 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 (60815161) FOR SIMILAR EVENT AND REVEALED NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED BY INSPECTION AND EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT THE IMPLANT WAS REMOVED DUE TO FRACTURED LOCATOR NO SYMPTOMS WAS REPORTED. PATIENT WILL RETURN FOR AN ADDITIONAL APPOINTMENT. TOOTH #13.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926717 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 60815161

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention