BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 10134272 · Received June 9, 2020

    Report

    Report Number
    1723170-2020-01621
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    December 5, 2019
    Report Date
    June 9, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS AVERAGE AGE OF PATIENTS IN THE MIS GROUP FOR THE ARTICLE. PATIENT GENDER IS THE MAJORITY GENDER OF PATIENTS IN MIS GROUP FOR THE ARTICLE. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS PUBLISHED AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. ARTICLE CITATION IS INCLUDED. SYSTEM PRODUCT NUMBER AND SERIAL NUMBER NOT PROVIDED IN JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO 510K PROVIDED AS SYSTEM IS UNKNOWN. NO EVALUATION WAS PERFORMED AS THIS EVENT WAS REPORTED IN LITERATURE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: YANG, PENG, ET AL. ¿PERCUTANEOUS SHORT-SEGMENT PEDICLE INSTRUMENTATION ASSISTED WITH O-ARM NAVIGATION IN THE TREATMENT OF THORACOLUMBAR BURST FRACTURES.¿ JOURNAL OF ORTHOPAEDIC TRANSLATION, VOL. 21, NO. 2020, 05 DEC. 2019, PP. 1-7., DOI:HTTPS://DOI.ORG/10.1016/J.JOT.2019.11.002. ABSTRACT: OBJECT: TO COMPARE THE CLINICAL AND RADIOLOGICAL OUTCOMES OF O-ARM NAVIGATION ASSISTED PERCUTANEOUS PEDICLE FIXATION AND OPEN FREEHAND PEDICLE FIXATION IN TREATMENT OF AO TYPE A3 THORACOLUMBAR BURST FRACTURES (TBFS) WITHOUT NEUROLOGICAL DEFICIT. METHODS: THIS RETROSPECTIVE STUDY INVOLVED 72 PATIENTS WITH TYPE A3 TBFS WHO UNDERWENT O-ARM NAVIGATION ASSISTED PERCUTANEOUS PEDICLE FIXATION (MIS GROUP) OR OPEN FREEHAND POSTERIOR PEDICLE FIXATION (OPPF GROUP) FROM SEPTEMBER 2015 TO DECEMBER 2017. DEMOGRAPHIC DATA AND CLINICAL CHARACTERISTICS WERE COMPARABLE BETWEEN THESE TWO GROUPS BEFORE SURGERY. OPERATING TIME, INTRAOPERATIVE BLOOD LOSS, AND THE TIME OF HOSPITALISATION STAY WERE ANALYSED. VISUAL ANALOG SCALE (VAS) SCORING AND OSWESTRY DISABILITY INDEX (ODI) WAS ASSESSED FOR EACH PATIENT PRE- AND POSTOPERATIVELY. RADIOGRAPHIC FOLLOW-UP WAS ASSESSED BY THE LOCAL KYPHOSIS ANGLE (LKA), VERTEBRAL WEDGE ANGLE (VWA), AND ANTERIOR BODY HEIGHT (ABH). THE ACCURACY OF SCREW PLACEMENT WAS EXAMINED BY COMPUTED TOMOGRAPHY. RESULTS: THE TWO GROUPS WERE MATCHED IN TERMS OF DEMOGRAPHIC AND CLINICAL FEATURES. INTRAOPERATIVE BLOOD LOSS WAS SIGNIFICANTLY LESS IN THE MIS GROUP COMPARED TO THE OPPF GROUP (P <(><<)> 0.05). THE AVERAGE TIME FOR HOSPITALISATION STAY IN THE MIS GROUP WAS SIGNIFICANTLY SHORTER THAN OPPF GROUP (P <(><<)> 0.05). HOWEVER, THE OPERATIVE TIME REVEALED NO SIGNIFICANT DIFFERENCE BETWEEN TWO GROUPS (P > 0.05). MEANWHILE, THE VAS SCORE AND ODI SCORE IN THE MIS GROUP WERE SIGNIFICANTLY LOWER THAN THAT IN THE OPPF GROUP AFTER SURGERY (P <(><<)> 0.05). RADIOGRAPHIC ASSESSMENTS REVEALED NO OBVIOUS DIFFERENCE BETWEEN THE 2 GROUPS IMMEDIATELY AFTER SURGERY OR AT THE FINAL FOLLOW-UP (P > 0.05); THE ACCURACY RATE OF PEDICLE SCREW POSITION IN THE MIS GROUP WAS HIGHER THAN OPPF GROUP (97.8% VS 78.5%, RESPECTIVELY; P <(><<)> 0.001). NO DEEP WOUND INFECTION, ADDITIONAL SURGERY, IMPLANT FAILURE, OR NEUROLOGICAL COMPLICATIONS WERE RECORDED IN EITHER GROUP. CONCLUSIONS: PERCUTANEOUS SHORT-SEGMENT PEDICLE INSTRUMENTATION ASSISTED WITH O-ARM NAVIGATION REPRESENTS AN EFFECTIVE AND SAFE ALTERNATIVE FOR TYPE A3 TBFS. IT HAS SEVERAL ADVANTAGES COMPARED WITH OPEN APPROACH, INCLUDING LESS BLOOD LOSS, SHORTER HOSPITALISATION, LESS POSTOPERATIVE PAIN, HIGHER ACCURACY OF PEDICLE SCREW PLACEMENT, AND FASTER RECOVERY PERIOD IN TREATING TBFS. HOWEVER, IT REQUIRES A LONGER LEARNING CURVE AND LONG-TERM RESULTS HAVE TO BE STUDIED IN OTHER WELL-DESIGNED STUDIES. THE TRANSLATIONAL POTENTIAL OF THIS ARTICLE: PERCUTANEOUS SHORT-SEGMENT PEDICLE INSTRUMENTATION ASSISTED WITH O-ARM NAVIGATION REPRESENTS AN EFFECTIVE AND SAFE ALTERNATIVE FOR TYPE A3 TBFS. THE UTILIZATION OF O-ARM NAVIGATION AND PERCUTANEOUS PEDICLE SCREW FIXATION GUARANTEED THE HIGH ACCURACY OF SCREW PLACEMENT, PROTECTED STAFF FROM RADIATION EXPOSURE AND OFFERED BENEFITS OF MINIMAL INVASIVE TECHNIQUE. OF THE 72 PATIENTS IN THE RETROSPECTIVE STUDY, 36 PATIENTS WERE TREATED WITH O-ARM NAVIGATION (MIS GROUP). SCREW POSITION/PEDICLE PERFORATION WAS GRADED AS PER THE 2-MM INCREMENT CLASSIFICATION: GRADE 0, COMPLETELY WITHIN THE PEDICLE; GRADE 1, PERFORATION <(><<)> 2 MM; GRADE 2, PERFORATION 2¿4 MM; AND GRADE 3, PERFORATION > 4 MM. IN ADDITION, GRADE 0 AND 1 WERE CONSIDERED ACCEPTABLE, WHEREAS GRADE 2 AND 3 WERE REGARDED AS PERFORATED. REPORTED EVENTS: IN THE MIS GROUP TREATED WITH O-ARM NAVIGATION, 18 SCREWS PLACED WERE CLASSIFIED AS GRADE 1, 3 SCREWS PLACED WERE CLASSIFIED AS GRADE 2, AND 1 SCREW PLACED WAS CLASSIFIED AS GRADE 3. NO CASES IN THE MIS GROUP WERE CONVERTED TO OPEN SURGERY. NONE OF THE PATIENTS HAD NEUROLOGICAL DEFICITS. NO COMPLICATIONS RELATED TO SURGERY SUCH AS INFECTION, BLOOD VESSEL, OR NEUROLOGICAL INJURY WERE OBSERVED, AND NO PATIENT NEEDED REVISION FOR CORRECTION LOSS OR INSTRUMENTATION FAILURE DURING FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598843 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR