BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE ACQUA IMPLANT 4.3X10

    MDR report key: 8269145 · Received January 22, 2019

    Report

    Report Number
    3008261720-2019-00334
    Event Type
    Injury
    Date Received
    January 22, 2019
    Date of Event
    January 8, 2019
    Report Date
    January 22, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016892
    PMA / PMN Number
    K133592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS SENT TO THE MANUFACTURER IN A MANNER UNSUITABLE FOR INVESTIGATION. ADDITIONAL PATIENT CODES (F10): 2277. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. THE DEVICE WAS NOT RECEIVED BY THE MANUFACTURER. THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM AND THE EVALUATION OF RELEVANT PRODUCTION RECORDS.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS SENT TO THE MANUFACTURER IN A MANNER UNSUITABLE FOR INVESTIGATION. ADDITIONAL PATIENT CODES (F10): 2104, 2277. 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 4.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 14 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE. CLINICIAN REPORTED PATIENT'S DISEASED MUCOUS MEMBRANE, PERI-IMPLANTITIS, SINUS PERFORATION, PAIN, MOBILITY, BLEEDING AND COMPLICATIONS IN THE SITE PREP. THE SITE WAS GRAFTED. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS. (B)(4).

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 4.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 14 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE. CLINICIAN REPORTED PATIENT'S DISEASED MUCOUS MEMBRANE, PERI-IMPLANTITIS, SINUS PERFORATION, PAIN, MOBILITY, BLEEDING AND COMPLICATIONS IN THE SITE PREP. THE SITE WAS GRAFTED. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59555 CM DRIVE ACQUA IMPLANT 4.3X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 116889I 07899878016892

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention BONE GRAFT| BONE GRAFT