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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 Muscle Weakness (1967); Numbness (2415)
Event Date 05/23/2021
Event Type  Injury  
Manufacturer Narrative
Patient age is the mean value of patients in the study. Patient gender is the majority value of patients in the study. Patient weight not available from the site. Event date is the online publication date of the article. Device lot number, or serial number, unavailable. 510(k) is dependent on the device model number. Therefore, is unavailable. Device manufacture date is dependent on the device lot/serial number, therefore is unavailable. No parts have been received by the manufacturer for evaluation. Concomitant medical products: other relevant device(s) are: product id: unk_oarm_sys, serial/lot #: unk. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Citation: robert y. North, michael j. Strong, timothy j. Yee, osama n. Kashlan, mark e. Oppenlander, paul park. Navigation and robotic-assisted single-position prone lateral lumbar interbody fusion: technique, feasibility, safety, and case series. World neurosurg. (2021) 15 2:221-230. Https://doi. Org/10. 1016/j. Wneu. 2021. 05. 097 abstract: -background: single-position prone lateral interbody fusion is a recently introduced technical modification of the minimally invasive retroperitoneal transpsoas approach for lateral lumbar interbody fusion (llif). Several technical descriptions of single-position prone llif have been published with traditional fluoroscopy for guidance. However, there has been no investigation of either threedimensional computed tomographyebased navigation for prone llif or integration with robotic assistance platforms with the prone lateral technique. This study evaluated the feasibility and safety of spinal navigation and robotic assistance for single-position prone llif. - methods: retrospective review of medical records and a prospectively acquired database for a single center was performed to examine immediate and 30-day clinical and radiographic outcomes for consecutive patients undergoing single-position prone llif with spinal navigation and/or robotic assistance. - results: nine patients were treated, 4 women and 5 men. Mean age was 65. 4 years (range, 46e75 years), and body mass index was 30. 2 kg/m2 (range, 24e38 kg/m2). The most common surgical indication was adjacent segment disease (44. 4%), followed by pseudarthrosis (22. 2%), spondylolisthesis (11. 1%), degenerative disc disease (11. 1%), and recurrent stenosis (11. 1%). Postoperative approach-related complications included pain-limited bilateral hip flexor weakness (4/5) and pain-limited left knee extension weakness (4/5) in 1 patient (11. 1%) and right lateral thigh numbness and dysesthesia in 1 patient (11. 1%). All cages were placed within quarters 2e3, signifying the middle portion of the disc space. There were no instances of misguidance by navigation. Conclusions: integration of spinal navigation and robotic assistance appears feasible, accurate, and safe as an alternative reported events: a (b)(6) female patient experienced bilateral hip flexion and left knee extension weakless, pain limited (4/5). A (b)(6) female patient experienced right anterolateral thigh numbness and dysthesia.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13079393
MDR Text Key288316122
Report Number1723170-2021-02959
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 12/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
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
Date Manufacturer Received12/02/2021
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: 12/23/2021 Patient Sequence Number: 1
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