BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM

    MDR report key: 9179538 · Received October 11, 2019

    Report

    Report Number
    9179538
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    September 18, 2019
    Report Date
    September 26, 2019
    Manufacturer
    DEPUY SPINE, LLC
    Product Code
    KXB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DOCTOR WAS USING THE PROBE FINDER FROM THE SYNTHES CORE 1 TRAY AND ABOUT 40MM OF THE TIP OF THE INSTRUMENT BROKE OFF IN THE PATIENT. THE SURGEON DID GET IT OUT AFTER USING SEVERAL INSTRUMENTS TO PULL IT OUT. INSTRUMENT BAGGED AND TAKEN TO QUALITY. OPERATIVE NOTE PREOPERATIVE DIAGNOSIS: LUMBAR SPONDYLOSIS. POSTOPERATIVE DIAGNOSIS: LUMBAR SPONDYLOSIS. PROCEDURES: L4-L5 POSTERIOR INSTRUMENTATION. L4-L5 POSTERIOR FUSION. PLACEMENT OF TRANSFORAMINAL LUMBAR INTERBODY GRAFT AT L4-L5. TRANSFORAMINAL LUMBAR INTERBODY FUSION L4-5. USE OF AUTOGRAFT AND ALLOGRAFT FOR SPINAL FUSION PURPOSES. USE OF INTRAOPERATIVE NEUROMONITORING AND FLUOROSCOPY. DESCRIPTION OF PROCEDURE: AT L5 ON THE RIGHT SIDE, WE ADVANCED OUR GEARSHIFT THROUGH THE PEDICLE INTO THE VERTEBRAL BODY, REMOVING THE GEARSHIFT. HER BONE BEEN EXCEPTIONALLY HARD AND I BELIEVE THE INSTRUMENT WAS SOMEWHAT AIR LOCKED. ANYWAYS, ON TWISTING AND REMOVING THE INSTRUMENT IT ACTUALLY BROKE OFF INTO THE VERTEBRAL BODY. IT TOOK A FAIR AMOUNT OF TIME IN MULTIPLE DIFFERENT INTERVENTIONS TO TRY TO GET THIS REMOVED. WE FELT THAT IT WAS CERTAINLY IMPERATIVE TO REMOVE THE INSTRUMENT FROM THE VERTEBRAL BODY. WE TRIED TO BE AS SPARING AS WE COULD WITH THE PEDICLE, SO THAT A SCREW COULD BE PLACED AFTERWARDS. IN THE END, WE DID GET THE INSTRUMENT OUT. THIS DID CORE OUT A FAIR AMOUNT OF THE SUPERFICIAL ASPECT OF THE PEDICLE. HERE WE THEN LEFT THIS WITHOUT A SCREW AND TURNED OUR ATTENTION TOWARDS THE TLIF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974375 EXPEDIUM PROBE KXB DEPUY SPINE, LLC 279702030 NW207194

    Patients

    Seq Age Sex Outcome Treatment
    1 17520 DA Other