BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V MTX 6M M 5.7MM 11.5MM

    MDR report key: 11702228 · Received April 21, 2021

    Report

    Report Number
    0002023141-2021-01001
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 3, 2021
    Report Date
    July 13, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019386
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TAPERED SCREW VENT (TSV6B11) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USAGE AND WHAT APPEARS TO BE DRIED BLOOD INSIDE THE IMPLANT DRIVE FEATURED. NO SIGNIFICANT DAMAGE WAS IDENTIFIED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. NO PRE-EXISTING CONDITION NOTED ON THE PER. THE REPORTED DEVICE WAS LOCATED ON TOOTH #19 (UNIVERSAL) AND WAS USED FOR APPROXIMATELY 11 DAYS. X-RAY OR PICTURE IMAGE WAS NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1240416. 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. STERILIZATION RECORD WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW BY LOT NUMBER (1240416) WAS PERFORMED FOR SIMILAR EVENTS USING KEYWORD CATEGORY MEDICAL: PAIN AND NO OTHER SIMILAR COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    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). WEIGHT: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. PMA/510K: K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS PLACED ON (B)(6) 2021 AT SITE #19. PATIENT COMPLAINED OF PAIN ON (B)(6) 2021. IMMEDIATE POST OP PANO AND CBCT SHOWED IMPLANT IN A GOOD POSITION. DESPITE PAIN CONTROL MEASURES, PATIENT WAS STILL EXPERIENCING PAIN AND OPTED TO HAVE THE IMPLANT REMOVED. PATIENT WILL RETURN IN 4 MONTHS TO ASSESS TO SEE IF THE PATIENT IS A CANDIDATE FOR A NEW IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597237 IMPL TAPERED SCR-V MTX 6M M 5.7MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TSV6B11 1240416 00889024019386

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention