BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUVASIVE PRECEPT SPINAL SYSTEM

    MDR report key: 6313154 · Received February 8, 2017

    Report

    Report Number
    2031966-2017-00003
    Event Type
    Death
    Date Received
    February 8, 2017
    Date of Event
    April 26, 2015
    Report Date
    January 4, 2017
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K122352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NUVASIVE PRODUCT IMPLANTED WAS NOT REPORTED TO HAVE EXHIBITED MALFUNCTION, ALTHOUGH SCREW PLACEMENT WAS REPORTEDLY INCORRECT. INITIAL INFORMATION RECEIVED INDICATED THE NEUROMONITORING DEVICE WAS UNKNOWN BUT HAS SUBSEQUENTLY BEEN DETERMINED TO BE A MEDTRONIC STEALTHSTATION TRIA NAVIGATION SYSTEM AS NOTED IN MDR 1723170-2015-00609. ITS STATUS HAS BEEN EVALUATED BY MEDTRONIC REPRESENTATIVES AND NO DEFICIENCIES WERE NOTED. IT IS NOT KNOWN IF THE STEALTHSTATION DEVICE WAS FUNCTIONING AS EXPECTED DURING THE SURGERY. USE OF THE NAVIGATION SYSTEM WITH NUVASIVE PRODUCTS HAS NOT BEEN EVALUATED. REVIEW OF IMPLANT MANUFACTURING RECORDS INDICATES NO NONCONFORMANCES WITH RESPECT TO MATERIAL TYPE, TREATMENTS OR DIMENSIONS. LABELING REVIEW: "CAUTION ENSURE THE K-WIRE IS NOT ADVANCING AS THE PATH IS CREATED OVER THE K-WIRE." "USE LATERAL FLUOROSCOPY TO PROPERLY MANAGE THE K-WIRE DURING PEDICLE PREPARATION TO ENSURE PROPER PLACEMENT AND AVOID ANTERIOR ADVANCEMENT OF THE K-WIRE." "CAUTION USE LATERAL FLUOROSCOPY TO PROPERLY MANAGE THE K-WIRE DURING PEDICLE PREPARATION TO ENSURE PROPER PLACEMENT AND AVOID ANTERIOR ADVANCEMENT OF THE K-WIRE. WATCH LINES ON K-WIRE TO HELP AVOID K-WIRE ADVANCEMENT OR PULLOUT." "THE CHALLENGE TO ANY MINIMALLY DISRUPTIVE PEDICLE SCREW PROCEDURE LIES IN THE INHERENT LACK OF DIRECT VISUALIZATION OF THE PEDICLE. MOREOVER, SCREW PLACEMENT IS TRADITIONALLY LIMITED TO 2D CONFIRMATION WITH FLUOROSCOPIC IMAGING... "NVM5 PROVIDES REALTIME FEEDBACK OF INITIAL PILOT HOLE FORMATION AND THROUGHOUT PEDICLE SCREW PLACEMENT." "THE SCREW TEST FUNCTIONS ALLOW THE SURGEON TO LOCATE AND EVALUATE SPINAL NERVES BY PROVIDING PROXIMITY INFORMATION BEFORE, DURING, OR AFTER BONE PREPARATION AND PLACEMENT OF BONE SCREWS. CONTINUOUS STIMULATED EMG IS SEAMLESSLY APPLIED TO PRECEPT® INSTRUMENTS TO PROVIDE REAL-TIME INFORMATION DURING: PEDICLE TARGETING USING I-PAS III, TAPPING, SCREW INSERTION". "POTENTIAL ADVERSE EVENTS AND COMPLICATIONS AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. INFREQUENT OPERATIVE AND POSTOPERATIVE COMPLICATIONS THAT MAY RESULT IN THE NEED FOR ADDITIONAL SURGERIES INCLUDE: EARLY OR LATE INFECTION; DAMAGE TO BLOOD VESSELS, SPINAL CORD OR PERIPHERAL NERVES; PULMONARY EMBOLI; LOSS OF SENSORY AND/OR MOTOR FUNCTION; IMPOTENCE; AND PERMANENT PAIN AND/OR DEFORMITY. RARELY, SOME COMPLICATIONS MAY BE FATAL." DEVICE NOT RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2015 DURING A VBR PROCEDURE AT L1 FOR A COMPRESSION FRACTURE IN AN (B)(6) YEAR-OLD FEMALE PATIENT IT WAS NOTED VIA FLUOROSCOPY AFTER INITIAL FIXATION SCREW PLACEMENT THAT 3 OF THE 4 SCREWS HAD BREACHED THE VERTEBRAL FORAMEN. NEUROLOGICAL MONITORING WAS REPORTEDLY USED BUT THE DEVICE USED WAS NOT NUVASIVE'S. THE SCREWS WERE REMOVED AND REPOSITIONED, CORRECTING THE BREACH. FINAL FIXATION WAS COMPLETED WITH NO FURTHER PROBLEMS NOTED. FLUOROSCOPY WAS USED TO CONFIRM PLACEMENT. THE FOLLOWING DAY THE PATIENT WAS NOTED TO HAVE EXCESSIVE POST-OPERATIVE BLEEDING AND UNDERWENT AN EMERGENCY PROCEDURE FOR A BLOOD TRANSFUSION AND POSSIBLE VASCULAR REPAIR. THE SURGEON REPORTED THE SEGMENTAL MEDULLARY ARTERY WAS DAMAGED. THE PATIENT SUBSEQUENTLY EXPIRED FOLLOWING THIS PROCEDURE ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93725 NUVASIVE PRECEPT SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE, NKB NUVASIVE, INC. 8805540006 JP6082

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death