MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; INSTRUMENT, STEREOTAXIC

Model Number UNK_NAV_SYS

Device Problem Human-Device Interface Problem (2949)

Patient Problems Nerve Damage (1979); Tissue Damage (2104)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

Patient identifiers not available from the site.510k not provided as confirmation of system model has not been provided.No parts have been returned to the manufacturer for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation world neurosurg.(2018) 118:e175-e184.Https://doi.Org/10.1016/j.Wneu.2018.06.148 - objective: pedicle screw placement remains challenging.The present study focuses on the comparison between 2 intraoperative-based neuronavigation systems (o-arm and airo) during thoracolumbar screw instrumentation.Methods: this is a prospective, comparative, nonrandomized study conducted in 2 french academic centers.The o-arm was used at the university hospital of bordeaux, whereas the airo was used at the university hospital of marseille.Routine computed tomography was performed on postoperative day 2 to evaluate pedicle screw placement.Measures of radiation exposure were extracted directly from reports provided by each system.The effective dose was calculated.Results: overall, 74 screws were placed in 11 patients in the o-arm group and 84 in 11 patients in the airo group.In the first group, 90.8% were rated as acceptable and 92.2% in the second (p > 0.05) according to the heary and gertzbein classifications, respectively, for thoracic and lumbar spine.Differences between both implantation systems were significant (p <(><<)> 0.05) concerning dose length product (235 and 1039 mgy/cm, in o-arm and airo, respectively), overall mean radiation dose received by 1 patient (3.52 and 15.6 msv in o-arm and airo, respectively), mean radiation dose per single scan (2.58 and 8.7 msv in oarm and airo, respectively), mean effective dose per instrumented level (1.04 and 3.9 msv in o-arm and airo, respectively), and radiation dose received by the primary surgeon (0.63 and 0 msv in o-arm and airo, respectively).Conclusions: intraoperative computed tomographye based navigation is a major innovation that improves the accuracy of pedicle screw positioning with acceptable patient radiation exposure and reduced surgical team exposure.Revision surgery for 1 patient due to neurotoxic pedicle screws.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The average patient mean body mass index was 24.52 kg/m2.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information: the following serial numbers were provided from the site; (b)(4) ssa gold (b)(4) ssa gold (b)(4) ssa gold o1000 s/n: (b)(4) ssa gold fusion (b)(4) ssa gold a search was conducted using the serial numbers provided between 09-01-2016 and 09-30-2017 and there was not enough information to match these devices with specific events reported in the article.

• Brand Name: MEDTRONIC NAVIGATION
• 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: 8313487
• MDR Text Key: 135347541
• Report Number: 1723170-2019-00574
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR