BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 10656021 · Received October 9, 2020

    Report

    Report Number
    1723170-2020-02666
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    August 17, 2020
    Report Date
    October 9, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ARTICLE. THIS VALUE IS THE MEAN AGE OF THE PATIENTS IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED 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. CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: UNK NAV COMP, SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN, UDI#: UNKNOWN. NO 510K PROVIDED AS THE 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: RYO TAMAKI, KEIJI WADA, KEN OKAZAKI, SURGICAL TECHNIQUE AND ACCURACY OF S2 ALAR-ILIAC SCREW INSERTION USING INTRAOPERATIVE O-ARM NAVIGATION: AN ANALYSIS OF 120 SCREWS, WORLD NEUROSURG. (2020), HTTPS://DOI.ORG/10.1016/J.WNEU.2020.08.123. SUMMARY: OBJECTIVE: TO EVALUATE THE SURGICAL TECHNIQUE AND ACCURACY OF S2 ALAR-ILIAC (SAI) SCREW PLACEMENT USING INTRAOPERATIVE O-ARM-BASED 3 -DIMENSIONAL NAVIGATION (OARM). METHODS: THIS STUDY INVOLVED 60 PATIENTS WHO UNDERWENT SAI SCREW PLACEMENT USING THE O-ARM SYSTEM BETWEEN SEPTEMBER 2013 AND SEPTEMBER 2019. THESE SURGERIES WERE PERFORMED BY 5 DIFFERENT SURGEONS. FOR OARM-BASED SAI SCREW INSERTION, A REFERENCE FRAME WAS ATTACHED TO THE SPINOUS PROCESS OF THE LOWER LUMBAR SPINE (USUALLY L4) SO AS NOT TO INTERFERE WITH SAI SCREW INSERTION AND TO FACILITATE SIMULTANEOUS L5-S POSTERIOR INTERBODY FUSION WITH NAVIGATION. THE NAVIGATED PROBE, ILIAC TAP, AND SCREWDRIVER WERE USED FOR SAI SCREW INSERTION. SCREW PLACEMENT ACCURACY AND SCREW LENGTH WERE ASSESSED USING POSTOPERATIVE COMPUTED TOMOGRAPHY. PERIOPERATIVE COMPLICATIONS WERE ALSO EVALUATED. RESULTS: MEAN AGE AT SURGERY WAS 68.1 (RANGE, 30E83) YEARS. IN TOTAL, 120 SCREWS WERE INSERTED. RATE OF ACCURATE SCREW PLACEMENT WAS 98.3% (118/120 SCREWS). THE 2 MISPLACED SCREWS BREACHED THE ANTERIOR CORTEX OF THE SACRUM. MEAN SCREW LENGTH WAS 85.6 (RANGE, 70E90) MM. THERE WERE NO SIGNIFICANT NEUROVASCULAR OR VISCERAL COMPLICATIONS PERIOPERATIVELY. CONCLUSIONS: SAI SCREW PLACEMENT CAN BE SAFELY PERFORMED USING THE INTRAOPERATIVE O-ARM SYSTEM AND OUR SURGICAL TECHNIQUE. REPORTED EVENTS: IT WAS REPORTED THAT TWO OF THE 120 (1.7%) SCREWS WERE MISPLACED, BREACHING THE LATERAL EDGE OF THE ANTERIOR SACRAL CORTEX. NO COMPLICATIONS RELATED TO SCREW PLACEMENT WERE OBSERVED. BOTH SCREWS WERE MISPLACED ANTERIORLY THROUGH THE LATERAL EDGE OF THE SACRUM. THE AUTHORS SPECULATED THAT THIS OCCURRED DUE TO ANTERIOR SLIPPAGE OF THE NAVIGATED INSTRUMENTS CAUSED BY THE HARD CORTICAL BONE OF THE ILEUM AND THE SHARP ANTERIOR SLANT OF THE CORTEX OF THE ILIUM TO THE ANTERIOR AT THE SI JOINT. THE NAVIGATED INSTRUMENTS DID NOT TRACK THIS MOVEMENT BECAUSE THE SURGEON TRIED TO KEEP THE TRAJECTORY ABOVE THE SCIATIC NOTCH. THIS FORCE MIGHT HAVE CAUSED THE NAVIGATED INSTRUMENTS TO BEND, WITH THE PROBE APPEARING TO BE ON THE RIGHT TRAJECTORY ACCORDING TO THE NAVIGATION SCREEN. THE ARTICLED CONCLUDED THAT SAI SCREW PLACEMENT USING THE O-ARM PROVED TO BE A SAFE, ACCURATE, AND RELIABLE TECHNIQUE. HOWEVER, A GAP MAY ARISE BETWEEN THE VIRTUAL INSTRUMENTS ON THE NAVIGATION SCREEN AND THE REAL DIRECTION OF THE INSTRUMENTS, AND THIS PHENOMENON SHOULD ALWAYS BE RECOGNIZED WHEN IT OCCURS. SEE ATTACHED ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119699 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR