BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIGUIDE - 2 IMPLANTS

    MDR report key: 16581833 · Received March 21, 2023

    Report

    Report Number
    3007362683-2023-00029
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    March 1, 2023
    Report Date
    May 23, 2023
    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. PRODUCT RETURN IS REQUESTED AND PRODUCT WILL BE EVALUATED AFTER RECEIPT. IN CASE ANY NEW OR ADDITIONAL INFORMATION WILL BE GAINED FROM THIS INVESTIGATION A FOLLOW-UP REPORT WILL BE SENT. TREND IS TRACKED AND MONITORED.

    Additional Manufacturer Narrative · 0

    FDA CODING WAS MISSED IN THE INITIAL REPORT. ADDING ADDITIONAL INVESTIGATION FINDINGS CODES 170 + 114. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. FDA CODING WAS MISSED IN THE INITIAL REPORT. ADDING ADDITIONAL TYPE OF INVESTIGATION CODES 3331 + 4114. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. FDA CODING WAS MISSED IN THE INITIAL REPORT. ADDING ADDITIONAL INVESTIGATION CONCLUSIONS CODE 12. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT SURGIGUIDE BROKE DURING USE. CLINICIAN POSTPONED SURGERY FOR A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12376 SURGIGUIDE - 2 IMPLANTS ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS NDP DENTSPLY SIRONA K.K. DDSC FACTORY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention #23: 26312:ASTRA TECH IMPLANT EV 3.6 S ¿ 9 MM.