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Model Number UNK_NAV_SYS
Device Problem Imprecision (1307)
Patient Problems Complaint, Ill-Defined (2331); Meningitis (2389)
Event Date 11/15/2019
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 screw insertion using intraoperative ct-based navigation in the article as specific patients could not be identified. This value reflects the gender of the majority of the patients who underwent screw insertion using intraoperative ct-based navigation 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: lee jun seok, son dong wuk, lee su hun, ki sung soon, lee sang weon, song geun sung, comparative analysis of surgical outcomes of c1¿2 fusion spine surgery between intraoperative computed tomography image based navigation-guided operation and fluoroscopy-guided operation, j korean neurosurg soc, volume 63, issue 2, 2020, pages 237-247, https://doi. Org/10. 3340/jkns. 2019. 0172. Summary: objective : fixation of the c1¿2 segment is challenging because of the complex anatomy in the region and the need for a high degree of accuracy to avoid complications. Preoperative 3d-computed tomography (ct) scans can help reduce the risk of complications in the vertebral artery, spinal cord, and nerve roots. However, the patient may be susceptible to injury if the patient¿s anatomy does not match the preoperative ct scans. The intraoperative 3d image-based navigation systems have reduced complications in instrument-assisted techniques due to greater accuracy. This study aimed to compare the radiologic outcomes of c1¿2 fusion surgery between intraoperative ct image-guided operation and fluoroscopy-guided operation. Methods : we retrospectively reviewed the radiologic images of 34 patients who underwent c1¿2 fusion spine surgery from january 2009 to november 2018 at our hospital. We assessed 17 cases each of degenerative cervical disease and trauma in a study population of 18 males and 16 females. The mean age was 54. 8 years. A total of 139 screws were used and the surgical procedures included 68 screws in the c1 lateral mass, 58 screws in c2 pedicle, nine screws in c2 lamina and c2 pars screws, four lateral mass screws in sub-axial level. Of the 34 patients, 19 patients underwent screw insertion using intraoperative mobile ct. Other patients underwent atlantoaxial fusion with a standard fluoroscopy-guided device. Results : a total of 139 screws were correctly positioned. We analyzed the positions of 135 screws except for the four screws that performed the lateral mass screws in c3 vertebra. Minor screw penetration was observed in seven cases (5. 2%), and major pedicle screw penetration was observed in three cases (2. 2%). In one case, the malposition of a c2 pedicle screw was confirmed, which was subsequently corrected. There were no complications regarding vertebral artery injury or onset of new neurologic deficits. The screw malposition rate was lower (5. 3%) in patients who underwent intraoperative ct-based navigation than that for fluoroscopy-guided cases (10. 2%). And we confirmed that the operation time can be significantly reduced by surgery using intraoperative o-arm device. Conclusion : spinal navigation using intraoperative cone-beam ct scans is reliable for posterior fixation in unstable c1-2 pathologies and can be reduced the operative time. Reported events: one (b)(6) year-old woman had an abnormal c2 pedicle screw position during a scan of the cervical spine which was removed and converted to a lamina screw. The patient recovered fully without any signs of neurological deficit. Two c1 screws were considered grade 1, one c2 screw was considered grade 1, one c2 screw was considered grade ii. Three patients underwent additional local block due to postoperative occipital neuralgia. One patient was diagnosed with meningitis.
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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 Key9987692
MDR Text Key189369132
Report Number1723170-2020-01283
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
Number of Events Reported1
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 04/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received04/15/2020
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: 04/22/2020 Patient Sequence Number: 1