BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12526173 · Received September 24, 2021

    Report

    Report Number
    0002023141-2021-02664
    Event Type
    Injury
    Date Received
    September 24, 2021
    Date of Event
    June 28, 2021
    Report Date
    March 2, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020047
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TAPERED SCREW VENT IMPLANT (TSVWB10) WAS RETURNED FOR INVESTIGATION. HOWEVER, ONE UNKNOWN ABUTMENT WAS NOT RETURNED. VISUAL EVALUATION OF RETURNED IMPLANT IDENTIFIED SOME SIGNS OF USE BUT NO APPARENT MALFUNCTION IDENTIFIED. BONE DEBRIS ON THE EXTERNAL THREADS. FUNCTIONAL TESTING WAS PERFORMED TO CHECK INTERNAL THREADS DAMAGED, IN-HOUSE DEVICES ASSEMBLED AS INTENDED, NO MALFUNCTION IDENTIFIED. PRE-EXISTING CONDITIONS AS NOTED ON THE PER WAS NONE. HOWEVER, DEVICE WAS LOCATED ON TOOTH SITE #UNK AND PLACED/REMOVED THE SAME DAY. X-RAY AND PICTURE IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1233945. 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 BY LOT NUMBER (1233945) WAS PERFORMED FOR SIMILAR EVENTS AND NO OTHER SIMILAR COMPLAINT WAS IDENTIFIED. DHR AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED FOR THE REPORTED UNK ABUTMENT AS THE ITEM/LOT NUMBER WAS NOT AVAILABLE. BASED ON THE AVAILABLE INFORMATION, DEVICES MALFUNCTION HAS NOT OCCURRED FOR IMPLANT AND MALFUNCTION FOR UNK ABUTMENT COULD NOT BE VERIFIED WITHOUT ITS RETURN. HENCE, THE EVENT WAS NONVERIFIABLE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT WAS LOOSE AND DAMAGED INTERNAL HEX DURING PLACEMENT. TOOTH LOCATION NOT REPORTED. THE PATIENTS CHART INDICATED THAT THE ABUTMENT WAS LOOSE SO THEY REMOVED THE IMPLANT. THE IMPLANT WAS PLACED AND REMOVED IN THE SAME PROCEDURE ON (B)(6), 2021. REPLACED WITH A NEW IMPLANT. THEY COULD NOT CONFIRM IF IT WAS A SEPARATE ABUTMENT OR THE IMPLANT MOUNT THAT WAS LOOSE IN THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422730 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB10 1233945 00889024020047

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention