BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT HEX ZYGOMATIC IMPL TI 35

    MDR report key: 7087554 · Received December 6, 2017

    Report

    Report Number
    3008261720-2017-06673
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    October 19, 2017
    Report Date
    December 6, 2017
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237567280
    PMA / PMN Number
    K141777
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC THE DENTIST REPORTED THAT IMMEDIATE LOAD PROCEDURE WAS PERFORMED.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT THE IMPLANT REMOVED 5 MONTHS AFTER PLACEMENT IN SITE #4 DUE TO MOBILITY AND A POSSIBLE INFECTION. IT WAS REPORTED THAT THE IMPLANT HAD FAILED TO OSSEOINTEGRATE AND TYPE II BONE QUALITY. CLINICIAN REPORTED INSUFFICIENT BONE QUALITY/QUANTITY AND SINUS MEMBRANE PERFORATION COULD HAVE INFLUENCED THE PROBLEM. THE PATIENT REPORTED PAIN AND SWELLING FOLLOWING THE IMPLANT LOSS. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. NO POST-OPERATIVE ISSUES REPORTED.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT THE IMPLANT REMOVED 5 MONTHS AFTER PLACEMENT IN SITE #4 DUE TO MOBILITY AND A POSSIBLE INFECTION. IT WAS REPORTED THAT THE IMPLANT HAD FAILED TO OSSEOINTEGRATE AND TYPE II BONE QUALITY. CLINICIAN REPORTED INSUFFICIENT BONE QUALITY/QUANTITY & SINUS MEMBRANE PERFORATION COULD HAVE INFLUENCED THE PROBLEM. THE PATIENT REPORTED PAIN AND SWELLING FOLLOWING THE IMPLANT LOSS. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. NO POST-OPERATIVE ISSUES REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869023 EXT HEX ZYGOMATIC IMPL TI 35 ENDOSSEOUS IMPLANT DZE NEODENT - JJGC S.A. 800082491 07898237567280

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention