BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 7150175 · Received December 27, 2017

    Report

    Report Number
    1723170-2017-05339
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    December 6, 2016
    Report Date
    December 27, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR MALES, 58 FEMALES, MEAN AGE, 14.7 PLUS/MINUS 2.3 YEARS, RANGING,11 TO 21. UEHARA M, TAKAHASHI J, KURAISHI S, ET AL. COMPUTER-ASSISTED SKIP PEDICLE SCREW FIXATION FOR ADOLESCENT IDIOPATHIC SCOLIOSIS. J ORTHOPAEDIC SCIENCE, 2017;22: 218-223. THE EXACT SYSTEM INFORMATION COULD NOT BE DETERMINED AS IT WAS NOT PROVIDED. HOWEVER, THE SYSTEM LISTED ON THIS FORM WAS AT THE ADDRESS LISTED IN THE ARTICLE DURING THE TIME SOME OF THE SURGERIES WERE COMPLETED. DEVICE MFG DATE WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. NO REQUESTS FOR SYSTEM SERVICE HAVE BEEN RECEIVED REGARDING THE REPORTED EVENTS. THE ARTICLE DOES NOT ALLEGE THAT THE MEDTRONIC SYSTEM CAUSED THE REPORTED EVENTS. REPORTED EVENTS/COMPLICATIONS ARE KNOWN INHERENT RISKS TO THIS PROCEDURE TYPE. NO ALLEGATION OF MALFUNCTION.

    Description of Event or Problem · 1

    PER ARTICLE, COMPUTER-ASSISTED SKIP PEDICLE SCREW FIXATION FOR ADOLESCENT IDIOPATHIC SCOLIOSIS BY UEHARA ET AL: OBJECTIVES: THIS STUDY INVESTIGATED THE CLINICAL AND RADIOLOGICAL RESULTS OF SKIP PEDICLE SCREW FIXATION FOR ADOLESCENT IDIOPATHIC SCOLIOSIS (AIS). SUMMARY OF BACKGROUND DATA: AT PRESENT, THE GENERALLY USED TECHNIQUE FOR PEDICLE SCREW FIXATION FOR THE SURGICAL CORRECTION OF AIS ENTAILS INSERTING A PEDICLE SCREW INTO EVERY SEGMENT ON THE CORRECTIVE SIDE AND INTO EVERY OR EVERY OTHER SEGMENT ON THE SUPPORTIVE SIDE. TO REDUCE OPERATION TIME, BLOOD LOSS, AND COST, WE DEVELOPED SKIP PEDICLE SCREW FIXATION TO ACHIEVE CORRECTION OF AIS USING FEWER PEDICLE SCREWS. METHODS: WE EVALUATED 62 CONSECUTIVE PATIENTS WHO HAD UNDERGONE COMPUTER-ASSISTED SKIP PEDICLE SCREW FIXATION FROM AUGUST 2005 TO JUNE 2014. ALL PATIENTS WERE FOLLOWED UP FOR AT LEAST TWO YEARS. WE INVESTIGATED THE CLINICAL RESULTS OF SKIP PEDICLE SCREW FIXATION FOR AIS. RESULTS: THE MEAN NUMBER OF FUSED VERTEBRAE WAS 10.3 ± 2.0, THE MEAN SURGICAL TIME WAS 242 ± 78 MIN, AND THE MEAN BLOOD LOSS VOLUME WAS 1060 ± 688 ML. THE MEAN COBB ANGLE OF MAIN THORACIC (MT) CURVE TWO YEARS AFTER SURGERY IMPROVED SIGNIFICANTLY COMPARED WITH THAT BEFORE SURGERY (P < 0.01). THE MEAN CORRECTION RATE OF MT CURVE IMMEDIATELY AFTER SURGERY WAS 62.4 ± 12.4% AND CORRECTION LOSS OF MTCURVE AT TWO YEARS AFTER SURGERY WAS 1.9 ± 5.8. THE SRS-22 SUBTOTAL SCORE TWO YEARS AFTER SURGERY IMPROVED SIGNIFICANTLY COMPARED TO THAT BEFORE SURGERY (P < 0.01). ALTHOUGH NO PATIENTS EXPERIENCED MAJOR COMPLICATIONS, EIGHT (12.9%) ENCOUNTERED MINOR COMPLICATIONS (TWO [3.2%] HAD MASSIVE BLOOD LOSS [>3000 ML], THREE [4.8%] HAD A BROKEN SCREW, ONE [1.6%] HAD A SET-SCREW THAT DROPPED OUT, ONE [1.6%] EXPERIENCED DEEP VEIN THROMBOSIS, ONE [1.6%] EXPERIENCED ACUTE RENAL FAILURE, AND ONE [1.6%] EXPERIENCED INTERCOSTAL NEURALGIA). REVISION SURGERY WAS NOT PERFORMED. CONCLUSIONS: SUBJECTS WITH AIS WHO UNDERWENT SKIP PEDICLE SCREW FIXATION HAD SIGNIFICANTLY IMPROVED CLINICAL AND RADIOLOGICAL PARAMETERS AT TWO YEARS AFTER SURGERY, INDICATING THAT SKIP PEDICLE SCREW FIXATION COULD BE USED TO SUCCESSFULLY TREAT AIS. A FRAMELESS STEREOTACTIC IMAGE-GUIDANCE SYSTEM (STEALTHSTATION TREON, AND STEALTHSTATION 7, MEDTRONIC, (B)(4)) WAS USED FOR PLANNING THE PEDICLE DIAMETER AND LENGTH, AS WELL AS FOR CORRECTING SCREW PLACEMENT AND FIXATION OF THE THORACIC AND LUMBAR SPINE. SCREW PERFORATION RATE (GRADE 2 AND 3) WAS 6.9% (60/865). OPERATIVE COMPLICATIONS WERE OBSERVED IN EIGHT (12.9%) PATIENTS; THE DETAILS ARE SHOWN IN TABLE 3. NO MAJOR COMPLICATION WAS OBSERVED. MINOR COMPLICATIONS WERE OBSERVED IN SIX PATIENTS, INCLUDING TWO (3.2%) WITH MASSIVE BLOOD LOSS (>3000 ML), THREE (4.8%) WITH A BROKEN SCREW, ONE (1.6%) WITH A SET-SCREW THAT DROPPED OUT, ONE (1.6%) WITH DEEP VEIN THROMBOSIS, ONE (1.6%) WITH ACUTE RENAL FAILURE AND ONE (1.6%) WITH INTERCOSTAL NEURALGIA. ONE SCREW (DIAMETER: 4.5 MM) INSERTED INTO UPPER INSTRUMENTED VERTEBRA (UIV) AND TWO SCREWS (DIAMETER: 5.5 MM) INSERTED INTO LIV BECAME BROKEN. OF THESE, TWO SCREWS BROKE TWO YEARS AFTER SURGERY AND ONE BROKE AFTER FOUR YEARS. WE CONSIDERED THAT SCREWS INSERTED INTO THE FUSED END WERE EASILY COMPROMISED WHEN ADJACENT VERTEBRAE WERE SKIPPED SINCE THIS WAS THE CASE FOR TWO OF THREE BROKEN SCREWS. HOWEVER, BONY UNION WAS ACHIEVED IN EACH CASE. FOLLOWING THESE COMPLICATIONS, WE INSERTED PEDICLE SCREWS INTO TWO CONSECUTIVE VERTEBRAE AT UIV AND LIV WHEN SCREW DIAMETER WAS LESS THAN 5.5 MM. INSUFFICIENT SCREW TORQUE WAS LIKELY THE CAUSE OF THE DROPPED-OUT SET SCREW. AS IT OCCURRED THREE MONTHS AFTER SURGERY WE BELIEVED THAT IT WAS NOT A SCREW STRENGTH ISSUE. BONY UNION WAS ACHIEVED IN THIS CASE. IN ONE PATIENT WHO HAD INTERCOSTAL NEURALGIA, THERE WAS NO SCREW PERFORATION. THERE WAS NO SEVERE COMPLICATION DUE TO SURGICAL INVASION. REVISION SURGERY WAS NOT PERFORMED DUE TO COMPLICATIONS IN OUR SERIES. SEVEN PATIENTS WHOSE POSTOPERATIVE INFLAMMATORY RESPONSE INCREASED WITHOUT EVIDENCE OF INFECTION WERE ADMINISTERED THERAPEUTIC ANTIBIOTIC AND DID NOT DEVELOP SUBSEQUENT SURGICAL SITE INFECTION. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928195 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) TREON

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention