BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 3.5X18

    MDR report key: 7029825 · Received November 14, 2017

    Report

    Report Number
    3008261720-2017-05057
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    February 23, 2017
    Report Date
    January 19, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569260
    PMA / PMN Number
    K150182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. AFTER THE EVALUATION WAS NOTICED THAT THE ITEM RECEIVED IS DIFFERENT FROM THE ITEM REPORTED. THEREFORE, THE LOT NUMBER WAS NOT CONSIDERED.

    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

    (B)(4) - THE CLINICIAN REPORTED THAT FIVE MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN ADA SITE #10 OF THE PATIENT¿S MOUTH, THE IMPLANT FAILED. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Description of Event or Problem · 0

    (B)(4). THE CLINICIAN REPORTED THAT FIVE MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN ADA SITE #10 OF THE PATIENT¿S MOUTH, THE IMPLANT FAILED.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT FIVE MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN ADA SITE #10 OF THE PATIENT¿S MOUTH, THE IMPLANT FAILED. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS

    Description of Event or Problem · 0

    (B)(4). THE CLINICIAN REPORTED THAT FIVE MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN ADA SITE #10 OF THE PATIENT¿S MOUTH, THE IMPLANT FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810263 CM DRIVE IMPLANT 3.5X18 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 33520I 07898237569260

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention