BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    ANKYLOS C/X

    MDR report key: 8837715 · Received July 29, 2019

    Report

    Report Number
    9612468-2019-03722
    Event Type
    Injury
    Date Received
    July 29, 2019
    Report Date
    July 29, 2019
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUBMISSION IS FOR THE 2Q19 ASR SERIOUS INJURY EVENTS FOR ENDOSSEOUS DENTAL IMPLANTS UNDER ASR EXEMPTION # 1997026. THIS REPORT SUMMARIZES 8737 SERIOUS INJURY EVENTS. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 8737 </NOE> REPORTED EVENTS. THIS SUBMISSION IS FOR THE 2Q19 ASR SERIOUS INJURY EVENTS FOR ENDOSSEOUS DENTAL IMPLANTS. THIS REPORT SUMMARIZES 8737 SERIOUS INJURY EVENTS WHERE PATIENTS' EXPERIENCED ENDOSSEOUS DENTAL IMPLANT FAILURE. OF THESE EVENTS THERE WERE: 1899 EVENTS WHERE INFECTION OCCURRED. 1720 EVENTS WHERE INFLAMMATION OCCURRED. 955 EVENTS WHERE PATIENTS' EXPERIENCED OSTEOLYSIS. 764 EVENTS WHERE EROSION OCCURRED. 61 EVENTS WHERE PATIENTS' EXPERIENCED PAIN. 10 EVENTS WHERE TISSUE DAMAGE OCCURRED. 6 EVENTS WHERE THE NERVE PROXIMITY WAS NOT OTHERWISE SPECIFIED. 5 EVENTS WHERE ABSCESS OCCURRED. 4 EVENTS WHERE A PATIENTS' EXPERIENCED SINUS PERFORATION. 4 EVENTS WHERE PATIENTS' EXPERIENCED SWELLING. 4 EVENTS WHERE NUMBNESS OCCURRED. 2 EVENTS WHERE PATIENTS' EXPERIENCED FISTULA. 2 EVENTS WHERE PATIENTS' EXPERIENCED HYPERSENSITIVITY. 1 EVENT WHERE WOUND DEHISCENCE OCCURRED. 1 EVENT WHERE A PATIENT EXPERIENCED INADEQUATE OSSEOINTEGRATION. 1 EVENT WHERE NECROSIS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630399 ANKYLOS C/X IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH NA

    Patients

    Seq Age Sex Outcome Treatment
    1