BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE PRECEPT SPINAL SYSTEM

    MDR report key: 11675483 · Received April 15, 2021

    Report

    Report Number
    2031966-2021-00054
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 15, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    NKB
    PMA / PMN Number
    K171894
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED AS NO PRODUCT MALFUNCTION WAS REPORTED. NO RADIOGRAPHS OR NEUROLOGICAL MONITORING REPORTS WERE PROVIDED. REVIEW OF THE REPORTED EVENT IDENTIFIED THAT THE SURGEON MAL PLACED A PEDICLE SCREW AND IMMEDIATELY LOST EMP SIGNAL ON NEURO MONITORING INDICATING A NERVE HAD BEEN DAMAGED. ALL FIXATION WAS REMOVED AND THE SURGERY WAS DISCONTINUED. THE ROOT CAUSE IS CONSIDERED TO BE THE RESULT OF SCREW MAL PLACEMENT AND NERVE IMPINGEMENT. THE PATIENT IS REPORTED TO BE SLOWLY RECOVERING BUT THERE HAS BEEN RE NO PLANNING A SECOND PROCEDURE AT THIS TIME. NO ADDITIONAL INVESTIGATION REQUIRED. LABEL REVIEW: "...POTENTIAL ADVERSE EVENTS AND COMPLICATIONS... AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. INFREQUENT OPERATIVE AND POSTOPERATIVE COMPLICATIONS...NERVE DAMAGE DUE TO SURGICAL TRAUMA... PARALYSIS..." "...WARNINGS, CAUTIONS AND PRECAUTIONS... THE IMPLANTATION OF SPINAL SYSTEMS SHOULD BE PERFORMED ONLY BY EXPERIENCED SPINAL SURGEONS WITH SPECIFIC TRAINING IN THE USE OF THIS SPINAL SYSTEM BECAUSE THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT..." "...USE LATERAL FLUOROSCOPY TO PROPERLY MANAGE THE K-WIRE DURING PEDICLE PREPARATION TO ENSURE PROPER PLACEMENT AND AVOID ANTERIOR ADVANCEMENT OF THE K-WIRE..."

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A PERCUTANEOUS SPINAL PROCEDURE FROM T10/T11 TO ADDRESS OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT. THE PHYSICIAN INSERTED A PEDICLE SCREW OVER THE GUIDE. AFTER INSERTING PEDICLE SCREWS INTO BOTH LEVELS AT T10 AN X-RAY WAS TAKEN FROM THE LATERAL POSITION REVEALING THAT THE DIRECTION OF PEDICLE SCREW INSERTED INTO RIGHT T10 WAS SHIFTED WHEN COMPARED WITH LEFT PEDICLE SCREW. THE PHYSICIAN REMOVED THE PEDICLE SCREW AND INSERTED ANOTHER PEDICLE SCREW. WHEN INSERTED THE PHYSICIAN CONFIRMED EMP HOWEVER THERE WERE NO WAVEFORM. THE PHYSICIAN DECIDED TO REMOVE ALL IMPLANTED SCREWS. THE PATIENT¿S LEFT LIMB RESPONDS BUT THE RIGHT LIMB HAS BECOME PARALYZED, BUT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566926 NUVASIVE PRECEPT SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INCORPORATED ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Disability