BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 23004049 · Received September 9, 2025

    Report

    Report Number
    23004049
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 19, 2025
    Report Date
    August 20, 2025
    Manufacturer
    STRYKER CORPORATION
    Product Code
    OCJ
    UDI-DI
    07613252639794
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE WERE PERFORMING A MULTIPLE LEVEL KYPHOPLASTY ON THE PATIENT. WE WERE WORKING ON THE L1 VERTEBRAE AND AFTER ACCESS WAS GAINED USING THE 11G ACCESS NEEDLE, THE 11G CURETTE WAS INTRODUCED. THE 11G CURETTE IS USED TO DISPLACE SCLEROTIC/CANCELLOUS BONE DURING PERCUTANEOUS BALLOON-ASSISTED VERTEBRAL AUGMENTATION PROCEDURES. THE CURETTE WAS INSERTED, AND THE PHYSICIAN WAS TAPPING THE DEVICE TO DISPLACE THE SCLEROTIC BONE WHEN THE CURETTE BECAME LODGED IN THE BONE. THE DEVICE WAS THEN TWISTED TO TRY AND DISPLACE THE BONE WHEN THE TIP OF THE DEVICE SHEARED OFF AND THE DISTAL PORTION OF THE CURETTE BROKE OFF, LEAVING A PIECE OF THE DEVICE IN THE VERTEBRAL BODY. THE TIP OFF THE CURETTE WAS WEDGED TO FAR WITHIN THE BONE AND NO ATTEMPT TO RETRIEVE IT WAS MADE. THE DECISION WAS MADE TO LEAVE THE FOREIGN BODY IN PLACE AND FILL THE VERTEBRAL BODY WITH CEMENT. THE STRYKER REP [REPRESENTATIVE] WAS PRESENT AND DISCOVERED THE PARTS OF THE METAL ARE MADE OF NITINOL AND MANY OF THE IMPLANTS USED TODAY ARE MADE OF THIS MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2440740 NA SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY OCJ STRYKER CORPORATION 0306621000 10435915 07613252639794

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Other