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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Urinary Retention (2119); Urinary Tract Infection (2120)
Event Date 11/01/2020
Event Type  Injury  
Manufacturer Narrative
Patient information was not included in the journal article. This value reflects 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 specific patients could not be identified. 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 serial number not provided in journal article. Udi not available for this system. 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.
 
Event Description
Citation: rafael de la garza ramos, murray echt, joshua a. Benton, yaroslav gelfand, michael longo, vijay yanamadala, reza yassari. Accuracy of freehand versus navigated thoracolumbar pedicle screw placement in patients with metastatic tumors of the spine. J korean neurosurg soc. 2020 november 1; doi. Org/10. 3340/jkns. 2020. 0001. Summary: objective : to compare the accuracy and breach rates of freehand (fh) versus navigated (nv) pedicle screws in the thoracic and lumbar spine in patients with metastatic spinal tumors. Methods : a retrospective review of adult patients who underwent pedicle screw fixation in the thoracic or lumbar spine for metastatic spinal tumors between 2012 and 2018 was conducted. Breaches were assessed based on the gertzbein and robbins classification and only screws placed >4 mm outside of the pedicle wall (lateral or medial) were considered breached. Results : a total of 62 patients received 547 pedicle screws (average 8 per patient) ¿ 34 patients received 298 pedicle screws in the fh group and 28 patients received 249 screws in the nv group. There were 40/547 breaches, corresponding to a breach and accuracy rate of 7. 3% and 92. 7%, respectively. The breach rate was 9. 7% in the fh group and 4. 4% in the nv group (chi-squared test, p
=
0. 017); this corresponded to an accuracy rate of 90. 3% and 95. 6%, respectively. Only one patient from the overall cohort (in the fh group) required revision surgery due to a medial breach abutting the spinal cord (1. 6% of all patients; 2. 9% of fh patients); no patient suffered organ, vessel, or neurological injury from screw breaches. Conclusion : navigated pedicle screw placement in patients with metastatic spinal tumors has a significantly higher radiographic acc uracy compared to the fh technique. However, the revision surgery was low and no patient suffered from clinically-relevant breach. Navigation also offers the advantage of real-time localization of spinal tumors and aids in targeting and resection of these lesions. Reported events: 1. Twenty-six patients experienced at least one perioperative complication: a. 3. 2% with urinary retention b. 8. 1% with pneumonia c. 3. 2% with urinary tract infection.
 
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Brand NameMEDTRONIC NAVIGATION
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12211366
MDR Text Key262927538
Report Number1723170-2021-01896
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK_NAV_SYS
Device Catalogue NumberUNK_NAV_SYS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/22/2021 Patient Sequence Number: 1
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