BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM

    MDR report key: 9176415 · Received October 10, 2019

    Report

    Report Number
    0002023141-2019-00871
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    February 28, 2019
    Report Date
    December 5, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL PMA/510(K) NUMBER- K061410, K011028, K013227

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). AN IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM (TSVWB8) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED PRODUCT IDENTIFIED NO VISIBLE EVIDENCE OF SIGNIFICANT WEAR, DAMAGE, OR DEFORMATION TO THE THREADS OR ANY OTHER PART OF THE IMPLANT. THE PRODUCT'S DIMENSIONS WERE MEASURED AND WERE FOUND TO BE WITHIN THE SPECIFICATIONS OF THE PRODUCT'S ENGINEERING DRAWING. THE REPORTED DEVICE WAS LOCATED ON TOOTH # 31 AND WAS REMOVED UPON PLACEMENT DUE TO THE REPORTED EVENT. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCES WERE NOTED. ALSO, A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT. COMPLAINANT REPORTED THAT FOR SOME REASON THE IMPLANT WAS NOT TORQUING INTO THE OSTEOTOMY. THE PRODUCT WAS RETURNED AND THE REPORTED COMPLAINT IS UN-CONFIRMED FOLLOWING INSPECTION AND EVALUATION OF THE PRODUCT. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WOULD NOT TORQUE INTO THE OSTEOTOMY. THE IMPLANT WAS REMOVED AND REPLACED WITH ANOTHER.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969566 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL 1223276

    Patients

    Seq Age Sex Outcome Treatment
    1