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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 Problem Unspecified Infection (1930)
Event Date 04/11/2014
Event Type  Injury  
Manufacturer Narrative
Date of event: 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: schatlo b, molliqaj g, cuvinciuc v, kotowski m, schaller k, tessitore e. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. Journal of neurosurgery spine. 2014. Doi: 10. 3171/2014. 3. Spine13714. If information is provided in the future, a supplemental report will be issued. [(b)(4)].
 
Event Description
Abstract: recent years have been marked by efforts to improve the quality and safety of pedicle screw placement in spinal instrumentation. The aim of the present study is to compare the accuracy of the spineassist robot system with conventional fluoroscopy-guided pedicle screw placement. Ninety-five patients suffering from degenerative disease and requiring elective lumbar instrumentation were included in the study. The robot cohort (group i; 55 patients, 244 screws) consisted of an initial open robot-assisted subgroup (subgroup ia; 17 patients, 83 screws) and a percutaneous cohort (subgroup ib, 38 patients, 161 screws). In these groups, pedicle screws were placed under robotic guidance and lateral fluoroscopic control. In the fluoroscopy-guided cohort (group ii; 40 patients, 163 screws) screws were inserted using anatomical landmarks and lateral fluoroscopic guidance. The primary outcome measure was accuracy of screw placement on the gertzbein-robbins scale (grade a to e and r [revised]). Secondary parameters were duration of surgery, blood loss, cumulative morphine, and length of stay. In the robot group (group i), a perfect trajectory (a) was observed in 204 screws (83. 6%). The remaining screws were graded b (n
=
19 [7. 8%]), c (n
=
9 [3. 7%]), d (n
=
4 [1. 6%]), e (n
=
2 [0. 8%]), and r ( n
=
6 [2. 5%]). In the fluoroscopy-guided group (group ii), a completely intrapedicular course graded a was found in 79. 8% (n
=
130). The remaining screws were graded b (n
=
12 [7. 4%]), c (n
=
10 [6. 1%]), d (n
=
6 [3. 7%]), and e (n
=
5 [3. 1%]). The comparison of ¿clinically acceptable¿ (that is, a and b screws) was neither different between groups (i vs ii [p
=
0. 19]) nor subgroups (subgroup ia vs ib [p
=
0. 81]; subgroup ia vs group ii [p
=
0. 53]; subgroup ib vs group ii [p
=
0. 20]). Blood loss was lower in the robot-assisted group than in the fluoroscopy-guided group, while duration of surgery, length of stay, and cumulative morphine dose were not statistically different. Robot-guided pedicle screw placement is a safe and useful tool for assisting spine surgeons in degenerative spine cases. Nonetheless, technical difficulties remain and fluoroscopy backup is advocated. Reported events: one patient being operated on with the robotic guidance system experienced an infection.
 
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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 Key8906198
MDR Text Key154756382
Report Number1723170-2019-04525
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeSZ
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
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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