BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIGUIDE - 2 IMPLANTS

    MDR report key: 15051365 · Received July 19, 2022

    Report

    Report Number
    3007362683-2022-00025
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    March 9, 2022
    Report Date
    September 16, 2022
    Manufacturer
    DENTSPLY IMPLANTS N.V.
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.

    Additional Manufacturer Narrative · 0

    FDA CODING WAS MISSED IN THE INITIAL REPORT. ADDING ADDITIONAL TYPE OF INVESTIGATION 10 + 3331. ADDING ADDITIONAL INVESTIGATION FINDING 213. ADDING ADDITIONAL INVESTIGATION CONCLUSIONS CODE 4310. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528059 SURGIGUIDE - 2 IMPLANTS ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS NDP DENTSPLY IMPLANTS N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 2 X 31010428 (LOT 464230 UND 457407)