BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM TITAMAX IMPLANT 3.5X9

    MDR report key: 7029962 · Received November 14, 2017

    Report

    Report Number
    3008261720-2017-05165
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    March 6, 2017
    Report Date
    January 19, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569284
    PMA / PMN Number
    K101207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    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.

    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 ON THE DAY THE DENTAL IMPLANT WAS PLACED, IN ADA SITE #3 OF THE PATIENT¿S MOUTH, A FAILURE OCCURRED UPON INSERTION. NO FURTHER COMPLICATIONS WERE OBSERVED.

    Description of Event or Problem · 0

    (B)(4) - THE CLINICIAN REPORTED THAT ON THE DAY THE DENTAL IMPLANT WAS PLACED, IN ADA SITE #3 OF THE PATIENT¿S MOUTH, A FAILURE OCCURRED UPON INSERTION. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. NO FURTHER COMPLICATIONS WERE OBSERVED.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT ON THE DAY THE DENTAL IMPLANT WAS PLACED, IN ADA SITE #3 OF THE PATIENT¿S MOUTH, A FAILURE OCCURRED UPON INSERTION. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. NO FURTHER COMPLICATIONS WEREOBSERVED.

    Description of Event or Problem · 0

    (B)(4) - THE CLINICIAN REPORTED THAT ON THE DAY THE DENTAL IMPLANT WAS PLACED, IN ADA SITE #3 OF THE PATIENT¿S MOUTH, A FAILURE OCCURRED UPON INSERTION. NO FURTHER COMPLICATIONS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810007 CM TITAMAX IMPLANT 3.5X9 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800176690I 07898237569284

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention