BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 7014306 · Received November 9, 2017

    Report

    Report Number
    1723170-2017-04578
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    February 10, 2014
    Report Date
    July 3, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. ARTICLE INDICATED THAT 39 MALE AND 36 FEMALE. THEREFORE, MALE WAS SELECTED AS PATIENT'S GENDER. MEAN AGE FOR MALE 57.7 AND FEMALE 57.9. THEREFORE, (B)(6) YEARS OLD WAS USED FOR THE PATIENT'S AGE. EVENT DATE IS APPROXIMATED BASED ON THE ARTICLE ACCEPTED DATE WHICH IS (B)(6) 2014. CITATION: BLAIR CALANCIE, MIRIAM L. DONOHUE, COLIN B. HARRIS,GREGORY W. CANUTE, AMIT SINGLA, KAITLIN G. WILCOXEN, AND ROSS R. MOQUIN. NEUROMONITORING WITH PULSE-TRAIN STIMULATION FOR IMPLANTATION OF THORACIC PEDICLE SCREWS: A BLINDED AND RANDOMIZED CLINICAL STUDY. PART 1. METHODS AND ALARM CRITERIA. J NEUROSURG SPINE 20:675¿691, 2014. PUBLISHED ONLINE APRIL 1, 2014; DOI: 10.3171/2014.2.SPINE13648. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INFORMATION PROVIDED IN THE JOURNAL ARTICLE OR FROM THE AUTHORS. NO REQUEST FOR SERVICE HAVE BEEN RECEIVED FROM THE CUSTOMER REGARDING THESE EVENTS. NO PARTS HAVE BEEN REPLACED OR RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    THE ATTACHED JOURNAL ARTICLE WAS FORWARDED BY A MEDTRONIC REPRESENTATIVE. USE OF IMAGING SYSTEM AND NAVIGATION SYSTEM FOR PEDICLE SCREW INSERTION WAS REPORTED. THE PURPOSE OF THIS STUDY IS TO DEVELOP, TEST, AND VALIDATE A NOVEL NEUROMONITORING METHOD FOR REVENTING MEDIAL MALPOSITIONING OF PEDICLE SCREWS IN THE THORACIC SPINE DURING SURGERY. FOR THIS STUDY, AUTHORS COLLECTED INTRAOPERATIVE DATA FROM 75 PATIENTS (39 MALE, MEAN AGE [± SD] 57.7 ± 12.5 YEARS; 36 FEMALE, MEAN AGE 57.9 ± 12.6 YEARS). THREE PATIENTS DID NOT UNDERGO POSTOPERATIVE CT SCANS TO EVALUATE PEDICLE SCREW POSITION. ANOTHER PATIENT WAS TESTED WITH AN INAPPROPRIATE STIMULUS PULSE DURATION OF 1.0 MSEC, MAKING COMPARISON OF HIS FINDINGS TO THOSE FROM OTHER PATIENTS INVALID. THUS WE OBTAINED USEABLE DATA FROM 71 PATIENTS. ALL PATIENTS PROVIDED INFORMED CONSENT AT ENROLLMENT IN THIS STUDY, WHICH WAS APPROVED BY THE INSTITUTIONAL REVIEW BOARDS OF BOTH (B)(6) HOSPITAL AND (B)(6) HOSPITAL (BOTH IN (B)(6)). 802 SCREWS WERE IMPLANTED BETWEEN THE T-1 AND L-1 VERTEBRAL LEVELS. AN INTRAOPERATIVE CT SCANNER (O-ARM) AND CO-REGISTRATION OF INTRAOPERATIVE IMAGES WITH A NEURONAVIGATION SYSTEM TO HELP DEFINE PEDICLE FINDER TRAJECTORY WAS USED IN A SMALL NUMBER OF PATIENTS (N = 6), BUT THIS ACTIVITY DID NOT INFLUENCE OUR STUDY PROTOCOL. PRIOR TO DISCHARGE, PATIENTS UNDERWENT THIN-SLICE (TYPICALLY 0.6-MM) SPIRAL CT IMAGING OF THEIR THORACIC SPINE. IMAGES WERE RECONSTRUCTED IN THE AXIAL AND SAGITTAL PLANES, STRIPPED OF IDENTIFYING FEATURES, AND¿FOR THE LEAST 2 ¿PASSES¿ THROUGH THE DATA. INTERRATER AND INTRARATER RELIABILITY WERE CALCULATED AND FOUND TO BE COMPARABLE TO REPORTS FROM OTHER CT-BASED STUDIES OF PEDICLE SCREW POSITION. SUBSEQUENT SCANS WERE SCORED BY A SINGLE READER BLINDED TO PATIENT IDENTITY, AFTER STATISTICAL ANALYSIS SHOWED THAT THIS READER HAD A HIGHER INTRARATER RELIABILITY THAN THE OTHER READERS. THE MAGNITUDE OF ANY MEDIAL AND LATERAL BREACHES OF THE PEDICLE WAS RECORDED, AS WAS THE EXTENT OF FORAMINAL ENCROACHMENT BY THE IMPLANTED SCREW. ELECTROPHYSIOLOGICAL TESTING WAS CARRIED OUT ON A TOTAL OF 802 IMPLANTED SCREWS AND A SOMEWHAT HIGHER NUMBER OF PEDICLE TRACKS (MORE PEDICLE TRACKS THAN SCREW PLACEMENTS WERE TESTED BECAUSE SOME TRACKS WERE REVISED). SOME PEDICLE TRACKS (N = 17) WERE NOT TESTED, MOSTLY DUE TO: 1) CONTAMINATION OF THE BALL-TIPPED PROBE IN ONE CASE, REQUIRING RESTERILIZATION BY AUTOCLAVE; AND 2) INCORRECT CONNECTIONS FROM AMPLIFIERS TO THE DATA ACQUISITION DEVICE. SUBJECTS COULD BE GROUPED INTO ONE OF 3 CATEGORIES FOR SURGICAL INDICATIONS: 1) CERVICAL DECOMPRESSION AND FUSION EXTENDING CAUDALLY TO T-3; 2) CORRECTION/FUSION OF THORACIC SCOLIOSIS AND/OR KYPHOSIS; AND 3) THORACOLUMBAR FUSION. AS A CONSEQUENCE, ALL LEVELS OF THE THORACIC SPINE WERE WELL REPRESENTED WITH SCREW PLACEMENTS. THIS IS A PROSPECTIVE, BLINDED AND RANDOMIZED STUDY USING A NOVEL COMBINATION OF INPUT (4-PULSE STIMULUS TRAINS DELIVERED WITHIN THE PEDICLE TRACK) AND OUTPUT (EVOKED ELECTROMYOGRAPHY FROM LEG MUSCLES) TO DETECT PEDICLE TRACK TRAJECTORIES THAT¿ONCE IMPLANTED WITH A SCREW¿WOULD CAUSE THAT SCREW TO BREACH THE PEDICLE¿S MEDIAL WALL AND ENCROACH UPON THE SPINAL CANAL. FOR COMPARISON, THE AUTHORS ALSO USED SCREW STIMULATION AS AN INPUT AND EVOKED ELECTROMYOGRAM FROM INTERCOSTAL AND ABDOMINAL MUSCLES AS OUTPUT MEASURES. INTRAOPERATIVE ELECTROPHYSIOLOGICAL FINDINGS WERE COMPARED WITH POSTOPERATIVE CT SCANS BY MULTIPLE REVIEWERS BLINDED TO PATIENT IDENTITY OR INTRAOPERATIVE FINDINGS. A TOTAL OF (B)(4) SCREWS ENDED UP WITH SCREW THREADS ENCROACHING ON THE SPINAL CANAL BY AT LEAST 2 MM. INTRAOPERATIVE FLUOROSCOPY WAS USED TO CHECK SCREW POSITION AFTER ALL INSTRUMENTATION WAS IMPLANTED, BUT BEFORE FINAL TIGHTENING. PULSE-TRAIN STIMULATION WITHIN THE PEDICLE TRACK USING A BALL-TIPPED PROBE AND ELECTROMYOGRAPHY FROM LOWER LIMB MUSCLES CORRECTLY PREDICTED ALL (B)(4) (100%) OF THESE MEDIALLY MALPOSITIONED SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793563 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00027-120

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| O| R