BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11816432 · Received May 13, 2021

    Report

    Report Number
    0002023141-2021-01245
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    April 6, 2021
    Report Date
    August 19, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020047
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM (TSVWB10) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WORN MARKINGS DUE TO USAGE. NO DAMAGE. THE RETURNED DEVICE WAS MEASURED AND VERIFIED TO MATCH DHR SPECIFICATIONS DRAWING. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED DEVICES LOCATION IS #30 AND USAGE ON THE SAME DAY. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1242120). 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 (1242120) FOR SIMILAR EVENT AND NO OTHER 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 (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT WEIGHT UNKNOWN / NOT PROVIDED. PMA/510K: K011028, K013227. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR LACK OF PRIMARY STABILITY EVENTS THAT DO NOT ALLEGE A DEFICIENCY WITH THE IMPLANT AND IDENTIFIED THAT THE REPORTED EVENT IS LIKELY DUE TO BIOLOGICAL FACTORS WHICH HAVE AN ADVERSE EFFECT ON IMPLANT STABILITY OR IS RELATED TO SURGICAL TECHNIQUE AND INSERTION TORQUE. DUE TO A WIDE RANGE OF EXTERNAL (NON-DESIGN/ NON-MANUFACTURING RELATED), IDENTIFYING A DEFINITIVE ROOT CAUSE IS GENERALLY NOT POSSIBLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED. SUMMARY REPORTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST IMPLANT WAS UNABLE TO BE PLACED DUE TO BEING TOO WIDE. DR. ATTEMPTED TO PLACE ANOTHER IMPLANT AT THE SAME SITE BUT HEARD A CROCK/POP SOUND UPON TORQUEING. PATIENT WILL NOT RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH #30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717927 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB10 1242120 00889024020047

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention