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Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 09/16/2019
Event Type  Injury  
Manufacturer Narrative
Patient information was not included in the journal article. Age: this value is the mean age of the patients reported in the article as specific patients could not be identified. Sex: 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: charles u, anthony a, evaristus n, morayo s, paul j, chinedu a. Computer-assisted brain surgery (neuronavigation) in abuja, north ce ntral nigeria: a 3-year retrospective review and practical challenges. Niger postgrad med j 2019;26:174-81. Doi: 10. 4103/npmj. Npmj_66_19. Summary: introduction: neuronavigation has become a standard of care in contemporary neurosurgery since more than two decades and is gradually being embraced in our local practice. It is, therefore, important to share our local experience, including practical challenges encountered with this technology. Aims and objectives: the aim of this study is to review and present our early experience with stealth neuronavigation and to discuss the practical challenges encountered with the application of this technology in this environment. Methodology: retrospective review of all consecutive cases over a 3-year period (january 2016¿december 2018). Admitting diagnosis, operations, histological diagnosis, adjuvant treatments and 6 months outcome were the major study parameters. Procedural challenges were also highlighted. Data were analysed using simple descriptive statistics, and results were presented in tables and figures. Results: a total of 30 procedures were conducted. Nineteen males and 11 females (male: female
1. 7:1). Youngest was (b)(6) months, oldest was (b)(6) years, mean
39 and standard deviation (sd)
19. 3. Operations performed were resection of mass lesion 18/30 (60%) and biopsy of mass lesion in 12/30 (40%) cases. Histological diagnostic yield was 100%. Mean duration of hospital stay was 2 days (sd
0. 25) for the biopsy group and 8 days (sd
1. 7) for the resection group. At 6 months review, 10/30 (33. 3%) have died following progression and/or complications of their primary pathology. Conclusions: wide spectrum of brain lesions were approached confidently with precision and minimal morbidity. No procedure-related mortality was recorded. Adjuvant treatments were easily deployed in line with a precise histological diagnosis. Practical challenges did not compromise the navigation process. Reported events: 1. 8/18 patients in the tumor resection group had incomplete resections. 2. At a 6 month review 10/30 of the patients had died following progression and or complications of their primary pathology. It was reported that there was no mortality related to the surgical procedure. 3. One (b)(6)-year-old male suffered a recurrence within nine months. A redo resection was performed but the patient succumbed to post-operative complications.
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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 Key9181747
MDR Text Key166180252
Report Number1723170-2019-05199
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2019
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 Received09/16/2019
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: 10/11/2019 Patient Sequence Number: 1