BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM

    MDR report key: 8806609 · Received July 19, 2019

    Report

    Report Number
    0002023141-2019-00438
    Event Type
    Injury
    Date Received
    July 19, 2019
    Date of Event
    June 4, 2019
    Report Date
    November 4, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). ONE TAPERED SCREW-VENT IMPLANT WITH MP-1 HA DUAL TRANSITION SELECTIVE SURFACE (TSVH11) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED PRODUCT IDENTIFIED A FRACTURED IMPLANT COLLAR. THERE WAS PRESENCE OF BONE RESIDUE AROUND THE EXTERNAL THREADS OF THE IMPLANT DUE TO USAGE. THE REPORTED DEVICE WAS IMPLANTED FOR IMPLANTED FOR APPROXIMATELY 11 YEARS. 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 THE COLLAR OF THE IMPLANT FRACTURED. THE IMPLANT WAS REMOVED AND REPLACED. THE REPORTED COMPLAINT IS CONFIRMED BASED ON VISUAL INSPECTION OF THE PRODUCT. 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

    (B)(4). ADDITIONAL PMA/510(K) NUMBER; K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DENTAL IMPLANT FRACTURED AT THE COLLAR. THE IMPLANT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601513 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 60790751

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention