BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE ACQUA IMPLANT, TITANIUM, 4.3X18

    MDR report key: 7030117 · Received November 14, 2017

    Report

    Report Number
    3008261720-2017-05275
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    August 30, 2017
    Report Date
    November 14, 2017
    Manufacturer
    NEODENT JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878018070
    PMA / PMN Number
    K150182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST

    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.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT AT THE TIME OF DENTAL IMPLANT PLACEMENT IN ADA SITE 28 OF THE PATIENT¿S MOUTH, THERE WAS NON-OSSEOINTEGRATION AND LOW TORQUE. THE CLINICIAN REPORTS THAT INSUFFICIENT BONE QUALITY COULD HAVE INFLUENCED THE PROBLEM. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT AT THE TIME OF DENTAL IMPLANT PLACEMENT IN ADA SITE 28 OF THE PATIENT¿S MOUTH, THERE WAS NON-OSSEOINTEGRATION AND LOW TORQUE. THE CLINICIAN REPORTS THAT INSUFFICIENT BONE QUALITY COULD HAVE INFLUENCED THE PROBLEM. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810013 CM DRIVE ACQUA IMPLANT, TITANIUM, 4.3X18 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT JJGC S.A. 31267I 07899878018070

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention