BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIGUIDE - 2 IMPLANTS

    MDR report key: 19557990 · Received June 18, 2024

    Report

    Report Number
    3007362683-2024-00006
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    April 15, 2024
    Report Date
    August 27, 2024
    Manufacturer
    DENTSPLY SIRONA K.K. DDSC FACTORY
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. SECTION H6 WAS DONE BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. DIGITAL PLANNING WILL BE INVESTIGATED AND PRODUCT INVESTIGATION WILL BE DONE ONCE RECEIVED IN THE INVESTIGATION LOCATION. THIS MDR SUBMISSION IS A LATE SUBMISSION. A CAPA HAS BEEN ISSUED.

    Additional Manufacturer Narrative · 0

    THE DHR REVIEW SHOWS THAT THERE WAS A CHANGE IN THE ORDER, THERE IS NO EVIDENCE THAT IT WAS DISCUSSED WITH THE CUSTOMER. THE INVESTIGATION OF THE DIGITAL DESIGN FILE AND ORDER NOTES SHOWS THAT INCORRECT DESIGN IS PERFORMED, NOT ACCORDING TO CUSTOMER'S ORDER NOTES. THE ROOT CAUSE IS IDENTIFIED AS OPERATOR ERROR WITH A SIMPLANT GUIDE DESIGN NOT ACCORDING TO CUSTOMER'S ORDER AND NOTES.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT THE SURGIGUIDE THAT TO BE USED FOR #37 TOOTH COULD NOT BE USE TO FOR THE IMPLANT SURGERY. THIS GUIDE IS TO BE REMADE WITH OPEN TUBE. DUE TO PROBLEMS WITH THE PATIENT'S OPENING, A 15MM DRILL COULD NOT BE INSERTED. #36 WAS ABLE TO BE IMPLANTED BUT #37 COULD NOT AND HAS BEEN POSTPONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338480 SURGIGUIDE - 2 IMPLANTS ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS NDP DENTSPLY SIRONA K.K. DDSC FACTORY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention