BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER

    MDR report key: 12561558 · Received October 1, 2021

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    Report

    Report Number
    12561558
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    August 23, 2021
    Report Date
    September 21, 2021
    Manufacturer
    PROVISION
    Product Code
    HTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTRAOPERATIVE, PHYSICIAN STATED THAT THE TIP OF A STRYKER 1.6MM TAPER SIDE CUTTING CARBIDE BUR (REF# (B)(4), LOT # 21109017, EXP 04/01/2026) BROKE OFF IN THE PATIENT'S BONE DURING A MAXILLOFACIAL SURGERY. THE TIP OF THE BUR WAS RETRIEVED OUT OF THE BONE BY PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1456772 STRYKER BURR, ORTHOPEDIC HTT PROVISION 1607-002-107 21109017

    Patients

    Seq Age Sex Outcome Treatment
    1 10585 DA