BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIGUIDE - 3 IMPLANTS

    MDR report key: 16938248 · Received May 16, 2023

    Report

    Report Number
    3007362683-2023-00031
    Event Type
    Injury
    Date Received
    May 16, 2023
    Report Date
    July 10, 2023
    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

    BASED ON THE INVESTIGATION, WE INITIATED CAPA-2023-220 AS THERE WAS A HUMAN ERROR DURING DESIGN OF THE BONE SUPPORTED SIMPLANT GUIDE, WHICH HAS LED TO ABORTED SURGERY.

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A SURGIGUIDE DID NOT PROPERLY FIT IN PATIENT'S MOUTH. THE CUSTOMER MADE AN INCISION AND DETECTED THAT THE GUIDE DIDN¿T FIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165197 SURGIGUIDE - 3 IMPLANTS ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS NDP DENTSPLY IMPLANTS N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown