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 Low Blood Pressure/ Hypotension (1914); Pain (1994); Paresis (1998); Tissue Damage (2104); Complaint, Ill-Defined (2331)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

Patient information was not included in the journal article.This value is the mean age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date the article was published 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: sardhara j, singh s, mehrotra a, bhaisora ks, das kk, srivastava ak, et al.Neuro-navigation assisted pre-psoas minimally invasive oblique lumbar interbody fusion (mi-olif): new roads and impediments.Neurol india 2019;67:803-12.Doi: 10.4103/0028-3886.263262.Abstract: introduction: minimally invasive spine-oblique lumbar interbody fusion (mis-olif) has emerged as a novel anterolateral, retroperitoneal, ¿pre-psoas¿ approach for lumbar interbody fusion for degenerative spinal instability, as well as for correction of deformity in patients without severe canal stenosis.In the last decade, the technique has gained popularity owing to several advantages like the minimal blood loss, minimal tissue dissection, preservation of posterior tension bands, better biomechanical strength, provision of mechanical stability to the lumbar spine, and a larger footprint of the implant, associated with it.It, thus, maximises load bearing on the cortical bone, and provides a better lordotic correction of the lumbar spine.The armamentarium is further boosted by the use of neuro-navigation and neuro-monitoring tools, thereby improving the surgical outcome.Material and methods: the clinical indications of mis-olif and various fixation methods [lateral lumbar fixation (llf) and percutaneous posterior pedicle fixation (ppf)] are discussed.The summary of the 15 patients on whom the technique was utilized, are discussed.The patients¿ demographics, clinical history and neurological examination data, pre- operative oswestry disability index (odi) and visual analogue scale (vas) score, intraoperative surgical details and postoperative follow up clinical as well as radiological data were assessed.Complications, readmissions, length of stay, estimated blood loss, surgical time and surgical outcome were also recorded.Results: 11 cases had grade 1 spondylolisthesis and 4 had grade 2 spondylolisthesis.One patient had both grade i and ii spondylolisthesis at different levels.13 patients had improvement in mechanical back pain and neurogenic claudication.Two patients had improvement in back pain but one-sided limb radiculopathy persisted, which was treated conservatively.The mean pre-operative odi score was 35 ± 6.1, which improved to 14.6 ± 4.1 at follow-up (range of follow-up: 1 to 10 months; mean 5.7 ± 3.3 months].The mean pre-operative vas score was 7 ± 0.7, which improved to 3.3 ± 0.4 at follow-up.Conclusions: the mis-olif technique at the l2¿l5 levels has shown encouraging early surgical outcomes with a good fusion rate and rapid recovery.While utilizing the unfamiliar oblique trajectory, the use of navigation can guide the surgeon in real time and also help in reducing the radiation exposure.Reported events: one (b)(6) male with mild back pain and neurogenic claudication treated with oblique lumbar interbody fusion (olif) and posterior pedicle fixation (ppf) had revision of one screw due to medial pedicle breach and post-operative transient gastroparesis which improved on medical management.One (b)(6) female with mild back pain and neurogenic claudication treated with olif and ppf had intra-operative transient hypotension (ith), end plate damage and cage displaced-transient sensory loss.It was noted that this was perhaps related to sympathetic chain injury.One (b)(6) male with mild back pain, bilateral l5 radiculopathy, lt canal stenosis (cs), and neurogenic claudication treated with olif and lateral lumbar fixation (llf) had the screw and plate pull out while the graft remained in situ.The screw and plate had to be removed.One (b)(6) male with mild back pain and neurogenic claudication treated with olif and lff had pain on the medial aspect of the thigh.The pain was intermittent and sharp shooting but decreased gradually on analgesic intake.One (b)(6) male with mild back pain treated with olif and oblique lateral lumbar stabilization through a reverse pedicle screw fixation (rpsf) had post-operative transient gastroparesis which improved on medical management.One (b)(6) female with mild back pain treated with olif and llf had post-operative transient gastroparesis which improved on medical management.Two patients had improvement in back pain but on one side, lumbar radiculopathy persisted which was treated conservatively.See attached 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: 9141665
• MDR Text Key: 161674110
• Report Number: 1723170-2019-05071
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• 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: 09/03/2019
• 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: 53 YR