BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 14939080 · Received July 6, 2022

    Report

    Report Number
    3004785967-2022-00438
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Date of Event
    January 19, 2022
    Report Date
    July 6, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY. AGE OR DATE OF BIRTH) THIS VALUE REFLECTS THE MEAN AGE OF THE PATIENTS WHO UNDERWENT THE CERVICAL SPINE PROCEDURE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX) THIS VALUE REFLECTS THE MAJORITY GENDER OF THE PATIENTS WHO UNDERWENT THE CERVICAL SPINE PROCEDURE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT) THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE ACCEPTED DATE. EVENT) THE ARTICLE CITATION IS INCLUDED. THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO 510K PROVIDED AS SYSTEM IS UNKNOWN. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ZHANG, K., CHEN, H., CHEN, K., YANG, P., YANG, H., & MAO, H. (2022). O-ARM NAVIGATED CERVICAL PEDICLE SCREW FIXATION IN THE TREATMENT OF LOWER CERVICAL FRACTURE-DISLOCATION. ORTHOPAEDIC SURGERY, 14(6), 1135¿1142. HTTPS://DOI.ORG/10.1111/OS.13227 SUMMARY: OBJECTIVE: TO EVALUATE THE SAFETY AND EFFICACY OF CERVICAL PEDICLE SCREW (CPS) PLACEMENT WITH O-ARM NAVIGATION IN THE TREATMENT OF LOWER CERVICAL FRACTURE-DISLOCATION. METHODS: A RETROSPECTIVE CLINICAL STUDY WAS PERFORMED INVOLVING 42 CONSECUTIVE PATIENTS WITH LOWER CERVICAL SPINE FRACTURE DISLOCATION WHO UNDERWENT CPS FIXATION SURGERY WITH O-ARM NAVIGATION (CPS GROUP) OR RECEIVED CONVENTIONAL LATERAL MASS SCREW (LMS) FIXATION SURGERY (LMS GROUP) BETWEEN AUGUST 2015 AND AUGUST 2019. ACCURACY OF CPS POSITION WAS EVALUATED BY POSTOPERATIVE CT. THE CLINICAL PARAMETERS INCLUDING PREOPERATIVE AND FINAL FOLLOW-UP JAPANESE ORTHOPAEDIC ASSOCIATION(JOA) SCORE AND AMERICAN SPINAL INJURY ASSOCIATION (ASIA) IMPAIRMENT SCALE, PREOPERATIVE SUB-AXIAL INJURY CLASSIFICATION (SLIC) SCORE, NUMBER OF FIXATION SEGMENTS, OPERATION TIME, INTRAOPERATIVE BLOOD LOSS, INJURY MECHANISM, INJURY LOCATION, SURGICAL COMPLICATIONS WERE ALSO ASSESSED BETWEEN THE TWO GROUPS. RESULTS: IN LMS GROUP, THE PREOPERATIVE SLIC SCORE WAS 7.5 +/- 0.9, ASIA SCORE IMPROVEMENT WAS 0.8 +/- 0.5, JOA SCORE IMPROVEMENT WAS 3.0 +/- 1.8, MEAN OPERATION TIME WAS 204 +/- 89 MIN, INTRAOPERATIVE BLOOD LOSS WAS 311 +/- 127 ML. IN CPS GROUP, THE PREOPERATIVE SLIC SCORE WAS 7.3 +/- 1.2, ASIA SCORE IMPROVEMENT WAS 0.9 +/- 0.5, JOA SCORE IMPROVEMENT WAS 3.2 +/- 2.4, MEAN OPERATION TIME IS 241 +/- 85 MIN, INTRAOPERATIVE BLOOD LOSS IS ABOUT 327 +/- 120 ML. THERE WAS NO SIGNIFICANT DIFFERENCE IN TERMS OF ABOVE CLINICAL PARAMETERS BETWEEN THE TWO GROUPS (P > 0.05), THE FIXATION SEGMENTS IN CPS GROUP (3.5 +/- 1.1) WERE LESS THAN THAT IN LMS GROUP (4.2 +/- 0.7) (P = 0.037). THE ACCURACY OF CPS INSERTION WAS EVALUATED BASED ON POSTOPERATIVE CT. OF ALL THE 118 CPSS, 83 (70.3%) WERE DEFINED AS GRADE 0; 27 (22.9%) AS GRADE 1; EIGHT (6.8%) AS GRADE 2; AND NONE AS GRADE 3. CPS MALPOSITION RATE IN THIS STUDY WAS 6.8%. IN THIS STUDY, THERE WAS NO DIRECT INTRAOPERATIVE OR POSTOPERATIVE COMPLICATION CAUSED BY CPS OR LMS INSERTION. ALL THE OPERATIONS WERE SUCCESSFULLY COMPLETED IN TWO GROUPS. ONE OF THE PATIENTS IN LMS GROUP PRESENTED CEREBROSPINAL FLUID LEAK CAUSED BY BONE FRAGMENT BROKEN OF THE DURAL SAC, WHICH LED TO DELAYED INCISION HEALING. CPS GROUP AND LMS GROUP BOTH HAD TWO PATIENTS WHO SUFFERED PULMONARY INFECTION AFTER SURGERY. A TOTAL OF 78.6% OF THE PATIENTS SHOWED EVIDENCE OF NEUROLOGIC RECOVERY. SATISFACTORY REDUCTION WAS ACHIEVED IN ALL CASES AND MAINTAINED THROUGHOUT THE FOLLOW-UP DURATION. CONCLUSION: IN THE TREATMENT OF LOWER CERVICAL SPINE FRACTURE-DISLOCATION, CERVICAL PEDICLE SCREW INSERTION WITH O-ARM NAVIGATION IS A SAFE AND EFFECTIVE METHOD FOR POSTERIOR FIXATION. REPORTED EVENTS: TWENTY TWO PATIENTS WITH A HISTOLOGY OF LOWER CERVICAL SPINE FRACTURE-DISLOCATION UNDERWENT A CERVICAL SPINE PROCEDURE. EIGHT SCREWS WERE NOTED TO BE IN MALPOSITION WITH A CORTICAL PERFORATION GREATER THAT TWO MILLIMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047947 O-ARM IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC (LITTLETON) UNK_OARM_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male