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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC RENAISSANCE SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number TPL0038
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Pulmonary Embolism (1498); Bacterial Infection (1735); Hematoma (1884); Complaint, Ill-Defined (2331); Impaired Healing (2378)
Event Date 02/17/2017
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: urakov t, hsuan-kan chang k, burks s, wang m. Initial academic experience and learning curve with robotic spine instrumentation. Neurosurgical focus. Volume 42 (5). Doi: 10. 3171/2017. 2. Focus175. If information is provided in the future, a supplemental report will be issued. (b)(4).
 
Event Description
Abstract: spine surgery is complex and involves various steps. Current robotic technology is mostly aimed at assisting with pedicle screw insertion. This report evaluates the feasibility of robot-assisted pedicle instrumentation in an academic environment with the involvement of residents and fellows. The renaissance guidance system was used to plan and execute pedicle screw placement in open and percutaneous consecutive cases performed in the period of december 2015 to december 2016. The database was reviewed to assess the usability of the robot by neurosurgical trainees. Outcome measures included time per screw, fluoroscopy time, breached screws, and other complications. Screw placement was assessed in patients with postoperative ct studies. The speed of screw placement and fluoroscopy time were collected at the time of surgery by personnel affiliated with the robot¿s manufacturer. Complication and imaging data were reviewed retrospectively. A total of 306 pedicle screws were inserted in 30 patients with robot guidance. The average time for junior residents was 4. 4 min/screw and for senior residents and fellows, 4. 02 min/screw (p
=
0. 61). Among the residents dedicated to spine surgery, the average speed was 3. 84 min/screw, while non-dedicated residents took 4. 5 min/screw (p
=
0. 41). Evaluation of breached screws revealed some of the pitfalls in using the robot. No significant difference regarding the speed of pedicle instrumentation was detected between the operators¿ years of experience or dedication to spine surgery, although more participants are required to investigate this completely. On the other hand, there was a trend toward improved efficiency with more cases performed. To the authors¿ knowledge, this is the first reported academic experience with robot-assisted spine instrumentation. Reported events: one patient operated on using the robotic guidance system developed a pulmonary embolism on day two after surgery. Two patients experienced problems with wound healing. One of the patients developed dehiscence and pseudomonas growth in the wound. One patient experienced a fall after discharge from the hospital and required burr holes for evacuation of a subdural hematoma. Two patients with l1-4 and l2-s1 instrumentation required additional surgeries to extend the constructs due to development of proximal junctional kyphosis.
 
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Brand NameRENAISSANCE 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 Key8905525
MDR Text Key154847664
Report Number1723170-2019-04518
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
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 NumberTPL0038
Device Catalogue NumberTPL0038
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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