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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.
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Manufacturer (Section D)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key8852535
MDR Text Key153079314
Report Number1723170-2019-04342
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received08/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK_NAV_SYS
Device Catalogue NumberUNK_NAV_SYS
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 Received07/05/2019
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 Treatment Data
Date Received: 08/01/2019 Patient Sequence Number: 1