BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    MDR report key: 8927380 · Received August 23, 2019

    Report

    Report Number
    0002023141-2019-00640
    Event Type
    Injury
    Date Received
    August 23, 2019
    Date of Event
    June 18, 2019
    Report Date
    November 15, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). AN IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM (ITEM # TSVB10) WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED PRODUCT IDENTIFIED SIGNS OF WEAR FROM USE IN THE FORM OF BIOLOGICAL RESIDUE COATING OF THE IMPLANT'S EXTERIOR, BUT NO OTHER SIGNS OF SIGNIFICANT DAMAGE OR DEFORMATION. THE RETURNED IMPLANT'S DIMENSIONS WERE MEASURED WITH AND FOUND TO BE WITHIN SPECIFICATIONS OF THE PRODUCT'S ENGINEERING. PICTURES OR X-RAY IMAGES OF THE IMPLANT SITE WERE NOT PROVIDED TO EVALUATE THE BONE LOSS. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCES WERE NOTED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (LOT # 1223469) FOR SIMILAR EVENT AND ONE OTHER COMPLAINT WAS IDENTIFIED FOR AN INFECTION. STERILIZATION RECORD WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINANT REPORTED PATIENT DEVELOP PERI-IMPLANTITIS. THE REPORTED COMPLAINT OF INFECTION AND BONE LOSS COULD NOT BE VERIFIED. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). ADDITIONAL 510K NUMBERS - K011028 AND K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERI-IMPLANTITIS AT THE IMPLANT SITE AND THE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720732 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 1223469

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention