BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLT TAP, 4.1, L25MM, SST/TAN

    MDR report key: 11812700 · Received May 12, 2021

    Report

    Report Number
    0001222315-2021-07863
    Event Type
    Injury
    Date Received
    May 12, 2021
    Date of Event
    October 24, 2018
    Report Date
    May 12, 2021
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    NDP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON APRIL 14TH, 2021 STRAUMANN USA, LLC RECEIVED A WRITTEN SUMMONS WHICH CONTAINED THE FOLLOWING INFORMATION: ON (B)(6) 2018 PATIENT HAD DENTAL IMPLANT SURGERY IN AREA UPPER TOOTH #8. DURING SURGERY DENTIST DROPPED A FOREIGN BODY, WHICH APPEARS TO HAVE BEEN THE TAP OF THE HAND PIECE BEING USED FOR THE IMPLANT SURGERY. THE FOREIGN BODY WAS DROPPED DOWN THE PATIENTS THROAT AND WAS ASPIRATED WHERE IT LODGED IN THE LOWER LOBE OF THE PATIENT'S RIGHT LUNG. PATIENT HAD X-RAY CONFIRMING METAL TOOL IN THE PATIENT'S LUNG. PATIENT UNDERWENT SURGERY AND HAD A LOBECTOMY OF THAT PART OF HIS LOWER RIGHT LOBE WHICH ENVELOPED THE FOREIGN BODY. FURTHER DOCUMENTATION STATES THAT THE DRILL BIT DID NOT STAY PROPERLY RETAINED IN THE CONNECTOR AS IT APPEARS TO BE MISSING AN O-RING OR SPRING TO KEEP IT RETAINED IN THE CONNECTOR. PATIENT UNDERWENT MULTIPLE PROCEDURES AND LOST PART OF HIS LUNG. NO FURTHER INFORMATION REGARDING PATIENTS' FOLLOW-UP SURGERY IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711384 BLT TAP, 4.1, L25MM, SST/TAN ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS - DENTAL IMPLANT ACCESORIES NDP INSTITUT STRAUMANN AG NK247

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention