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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 Hemorrhage/Bleeding (1888); Impaired Healing (2378); Spinal Cord Injury (2432); Post Operative Wound Infection (2446)
Event Date 03/08/2011
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: kantelhardt s, martinez r, baerwinkel s, burger r, giese a, rohde v. Perioperative course and accuracy of screw positioning in conventional, open robotic-guided and percutaneous robotic-guided, pedicle screw placement. European spine journal. 2011. Doi 10. 1007/s00586-011-1729-2. If information is provided in the future, a supplemental report will be issued. (b)(4).
 
Event Description
Abstract: robotic-guided and percutaneous pedicle screw placement are emerging technologies. We here report a retrospective cohort analysis comparing conventional open to open robotic-guided and percutaneous robotic-guided pedicle screw placement. 112 patient records and ct scans were analyzed concerning the intraoperative and perioperative course. 35 patients underwent percutaneous, 20 open robotic guided and 57 open conventional pedicle screw placement. 94. 5% of robot-assisted and 91. 4% of conventionally placed screws were found to be accurate. Percutaneous robotic and open robotic-guided subgroups did not differ obviously. Average x-ray exposure per screw was 34 s in robotic-guided compared to 77 s in conventional cases. Subgroup analysis indicates that percutaneously operated patients required less opioids, had a shorter hospitalization and lower rate of adverse events in the perioperative period. The use of robotic guidance significantly increased accuracy of screw positioning while reducing the x-ray exposure. Patients seem to have a better perioperative course following percutaneous procedures. Reported events: one major hemorrhage was observed intraoperatively in procedures using the robotic guidance system. Six dural tears were observed intraoperatively in procedures using the robotic guidance system. One infection was observed postoperatively after a procedure using the robotic guidance system. 8 patients undergoing procedures using the robotic guidance system required revisions due to misplaced screws. 5 patients undergoing procedures using the robotic guidance system required secondary sutures under local anesthesia to be placed because of wound healing disorders and infections.
 
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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 Key8906142
MDR Text Key154833482
Report Number1723170-2019-04524
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
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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