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

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.

• Brand Name: SPINEASSIST SYSTEM
• Type of Device: INSTRUMENT, 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 Key: 8905570
• MDR Text Key: 155199665
• Report Number: 1723170-2019-04519
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K073467
• Number of Events Reported: 1
• 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 Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: TPL0001
• Device Catalogue Number: TPL0001
• 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 Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/01/2008
• 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