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 Ossification (1428); Abscess (1690); Bacterial Infection (1735); Unspecified Infection (1930); Myocardial Infarction (1969); Urinary Retention (2119); Weakness (2145); Complaint, Ill-Defined (2331); Numbness (2415)

Event Date 08/02/2017

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.Date of event: 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: xilin liu, jacob r joseph, brandon w smith, yamaan saadeh, paul park, analysis of intraoperative cone-beam computed tomography combined with image guidance for lateral lumbar interbody fusion, operative neurosurgery, volume 14, issue 6, june 2018, pages 620¿626, h ttps://doi.Org/10.1093/ons/opx176 summary: background: minimally invasive lateral lumbar interbody fusion (llif) is traditionally performed with biplanar fluoroscopy.Recent literature demonstrates that intraoperative cone-beam computed tomography combined with spinal navigation can be safely utilized for localization and cage placement in llif.Objective: to evaluate the accuracy and safety of cage placement using spinal navigation in llif, as well as to evaluate the radiation exposure to surgeon and staff during the procedure.Methods: the authors performed a retrospective analysis of a prospectively acquired database of patients undergoing llif with image- based navigation performed from april 2014 to july 2016 at a single institution.The medical records were reviewed, and data on clinical outcomes, cage accuracy, complications, and radiation exposure were recorded.All patients underwent a minimum 30-d clinical follow-up to assess intraoperative and short term complications associated with their llif.Results: sixty-three patients comprising 117 spinal levels were included in the study.There were 36 (57.1%) female and 27 (42.9%) male patients.Mean age was 62.7 yr (range 24-79 yr).A mean 1.9 (range 1-4) levels per patient were treated.Cages were placed in the anterior or middle of 115 (98.3%) disc spaces.Image-guided cage trajectory was accurate in 116/117 levels (99.1%).In a subgroup analysis of 18 patients, mean fluoroscopy time was 11.7 ± 9.7 s per level.Sixteen (25.4%) patients experienced a complication related to approach.Conclusion: use of intraoperative cone-beam computed tomography combined with spinal navigation for llif results in accurate and safe cage placement as well as significantly decreased surgeon and staff radiation exposure.Reported events: sixteen patients encountered approach related complications.Nine patients had mild transient hip weakness.Three patients had transient hip/thigh numbness.Four patients had persistent mild hip/thigh numbness at last follow-up.Two patients had superficial wound infections.One patient developed a psoas abscess treated with percutaneous drainage.One patient developed asymptomatic myositis ossificans.Three patients had perioperative myocardial infarctions.One patient developed miller-fisher acute intermittent demyelinating polyneuropathy.Two patients had uncomplicated ileus.One patient had transient urinary retention.One patient had perioperative pneumonia.

• 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: 8852535
• MDR Text Key: 153079314
• Report Number: 1723170-2019-04342
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• 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: 07/05/2019
• 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: 63 YR