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

Model Number UNK_NAV_SYS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Weakness (2145); Numbness (2415)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

Patient information was not included in the journal article.This value is the mean age of the patients who underwent navigation system-assisted minimally invasive dlif in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients who underwent navigation system-assisted minimally invasive dlif in the article as specific patients could not be identified.Please note that this date is based off of the date the article was accepted as the event dates were not provided in the published literature.Article citation is included.System product number and serial number not provided in journal article.Udi not available for this system.No 510k provided as system is unknown.No evaluation was performed as this event was reported in literature.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: jianzhong jiang, bs, fengping gan, ms, haitao tan, md, zhaolin xie, bs, xiang luo, ms, guoxiu huang, ms, yin li, ms, shengbin huang, ms, effect of computer navigation-assisted minimally invasive direct lateral interbody fusion in the treatment of patients with lumbar tuberculosis, medicine (2018) 97:48, http://dx.Doi.Org/10.1097/md.0000000000013484.Summary: the benefits of navigation-assisted technologies are not entirely understood.Therefore, this study aimed to examine the outcomes of patients with lumbar tuberculosis who received computer navigation-assisted minimally invasive direct lateral interbody fusion (dlif).This was a (b)(6) study of 33 patients with lumbar tuberculosis who underwent minimally invasive dlif at the department of spine and orthopedics of guigang people¿s hospital (guangxi, china) between (b)(6) 2015 and (b)(6) 2016.The patients were p athologically diagnosed as lumbar tuberculosis and grouped into the navigation-assisted fluoroscopy (nav; n = 18) and non-navigation-assisted fluoroscopy (non-nav; n = 15) groups.X-ray exposure and operation times were assessed in all patients.All surgical procedures were successfully completed.No case was converted into open surgery.The nav group had longer surgical preparation time but shorter operation time compared with the non-nav group (both p <(><<)>.01).Total operation time showed no significant difference between the 2 groups (p =.1).The time of radiation exposure in the non-nav group was longer compared with that of the nav group (53.2 ± 9.9 vs 13.5 ± 2.6 s; p <(><<)>.01).There were no significant differences regarding intraoperative blood loss, postoperative drainage volume, length of hospital stay, bone fusion and complications between the 2 groups (all p >.05).Computer navigation-assisted minimally invasive dlif could significantly reduce intraoperative radiation exposure, with no increase in total operation time.Reported events: two patients had anterior numbness of the ipsilateral thigh and five patients felt weak when flexing the hip.These patients received physiotherapy, acupuncture, and neurotrophic drugs, and recovered within 1 to 3 months of the surgery.

• 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: 9088269
• MDR Text Key: 161774766
• Report Number: 1723170-2019-04938
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/27/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR