BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 24461394 · Received February 26, 2026

    Report

    Report Number
    2411236-2026-00001
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    February 9, 2026
    Report Date
    February 26, 2026
    Manufacturer
    PRIMA DENTAL GROUP
    Product Code
    EJL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE THE DENTIST WAS USING A HENRY SCHEIN SURGIPRO 45 HANDPIECE AND PERFORMING A SURGICAL EXTRACTION AND BONE GRAFT PROCEDURE IN THE SOCKET OF #13 TOOTH ON (B)(6) 2026 ON A 75 YEAR OLD FEMALE PATIENT A PIECE OF THE BUR BROKE OFF INTO THE PATIENT'S MOUTH. THE DENTIST'S OFFICE GOT THE PATIENT BACK ON (B)(6) 2026 TO TAKE AN XRAY AND DISCOVERED THE BROKEN PIECE OF THE BUR WAS LOCATED IN THEIR GUM. THE OFFICE THEN SAW HER THEN ON (B)(6) 2026 TO REMOVE THE PIECE OF BUR. THEY HAD TO NUMB HER TO OPEN THE SITE BACK UP TO REMOVE THE BROKEN BUR TIP THAT BECAME LODGED AND THEN PLACE A NEW GRAFT AND SUTURE IT UP AGAIN. THE BROKEN BUR PIECE WAS SUCCESSFULLY REMOVED WITH NO FURTHER COMPLICATIONS. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513847 HENRY SCHEIN SURGICAL BUR FG 557 EJL PRIMA DENTAL GROUP 1658894

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention