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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SPINEASSIST SYSTEM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC SPINEASSIST SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number TPL0001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Impaired Healing (2378); Tissue Breakdown (2681)
Event Date 07/20/2017
Event Type  Injury  
Manufacturer Narrative
Date of event: please note that this date is based off the date of publication of the article as the actual event date was not provided. The reported event was from the following literature article: alaid a, von eckardstein k, smoll n, solomiichuk v, rohde v, martinez r, schatlo b. Robot guidance for percutaneous minimally invasive placement of pedicle screws for pyogenic spondylodiscitis is associated with lower rates of wound breakdown compared to conventional fluoroscopy-guided instrumentation. Neurosurgery review. 2018. 41: 489-496. Doi: 10. 1007/s10143-017-0877-1. If information is provided in the future, a supplemental report will be issued. (b)(4).
 
Event Description
Abstract: postoperative wound healing can pose a problem in patients undergoing instrumented surgery for pyogenic spondylodiscitis. Robotic guidance allows the minimally invasive placement of pedicle screws in the thoracolumbar spine. We assessed whether using this technique to perform minimally invasive surgery had an impact on wound healing in patients with pyogenic spondylodiscitis when compared to conventional open fluoroscopy-guided surgery. We reviewed charts of 206 consecutive patients who underwent instrumentation for pyogenic spondylodiscitis. The need for wound revision was the primary outcome measure. Patient variables and comorbidities as well as surgical technique (robotic versus fluoroscopy-guided) were analyzed. We also compared fluoroscopy times between the two groups. Multivariate regression analysis was performed to identify predictors of wound breakdown. A total of 206 patients underwent surgery for spondylodiscitis. Robotic surgical assistance was used for percutaneous instrumentation in 47. 6% of cases (n
=
98). Wound healing problems requiring revision occurred in 30 out of 206 patients (14. 6%). Univariate analysis revealed a potential association of wound breakdown with (1) robotic technique, (2) age > 70 years, and (3) the presence of (b)(6). After multivariate correction however, only robotic technique retained significance with an odds ratio of 0. 39 (ci 95% 0. 16¿0. 94; p
=
0. 035). Wound revision was required in eight out of 98 patients (8. 1%) in the robot group and 22/108 (20%) in the conventional surgery group. Fluoroscopy times were significantly lower in the robot group with a mean of 123 ± 86 s in comparison with a mean of 157 ± 99 s in the conventional group (p
=
0. 014). While initially designed to improve the accuracy of pedicle screw placement, robot-assisted minimally invasive technique had a tangible effect on both radiation exposure and the rate of wound breakdown in patients with pyogenic spondylodiscitis in our large single-center study. Reported events: 1. 8 patients in the robotic assisted surgery group being treated for pyogenic spondylodiscitis experience wound healing problems and required a wound revision.
 
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Brand NameSPINEASSIST SYSTEM
Type of DeviceINSTRUMENT, STEREOTAXIC
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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8905570
MDR Text Key155199665
Report Number1723170-2019-04519
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K073467
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 08/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTPL0001
Device Catalogue NumberTPL0001
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 Received10/12/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/01/2008
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: 08/19/2019 Patient Sequence Number: 1
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