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Model Number 9733858
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cerebrospinal Fluid Leakage (1772); Edema (1820); Facial Nerve Paralysis (1846)
Event Date 11/19/2019
Event Type  Injury  
Manufacturer Narrative
Patient age is the mean value of patients in the study. Patient gender was 19 males and 19 females. Patient weight not available from the site. Event date is the accepted date of the publication. Device lot number, or serial number, unavailable. No parts have been received by the manufacturer for evaluation. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. If information is provided in the future, a supplemental report will be issued.
Event Description
Citation: tomasz szmuda, pawel sloniewski, shan ali, pedro m. Goncalves pereira, mateusz pacholski, fanar timemy, agnieszka sabisz, edyta szurowska, sara kieronska. Reliability of diffusion tensor tractography of facial nerve in cerebello-pontine angle tumours. Polish journal of neurology and neurosurgery. Doi: 10. 5603/pjnns. A2020. 0001 abstract: aim of the study: this study aimed to verify the accuracy of preoperative visualisation of the facial nerve (fn) by magnetic resonance-based (mr) diffusion tensor imaging-fibre tracking (dti-ft) with neuronavigation system integration in patients with cerebello-pontine angle (cpa) tumours. Clinical rationale for the study: complete excision with preservation of the fn remains the critical goal of today¿s vestibular schwannoma (vs) surgery. Dti-ft of the fn with neuronavigation is yet to be fully evaluated, and could make surgery safer. Materials and methods: this was a prospective cohort study in which 38 consecutive patients with a cpa tumour (32 vss, five meningiomas and one epidermoid cyst) were operated on via the retrosigmoid route from 2013 to 2019. The course of the fn was simulated before surgery using stealthviz and the images were transferred to the medtronic s7 neuronavigation system. The fn location reconstructed by dti-ft was verified during the surgery. Results. Mr acquisition was inappropriate in three patients (7. 9%). Dti-ft correctly predicted the course of the fn in 31 of the 38 patients; the discordance rate was 18. 4%. The accuracy of dti-ft was 81. 6% (95% ci: 65. 67-92. 26), sensitivity 88. 57% (95% ci: 73. 26-96. 80) and positive predictive value was 91. 18% (95% ci: 90. 17-92. 09). The reliability of the neuronavigation-integrated visualisation of the fn did not depend on the tumour size (p
0. 85), but the method was more accurate when the nerve was compact in shape (p
0. 03, area under curve (auc) 0. 87, 95% ci: 0. 60-1. 00) and in females (p
0. 04, auc 0. 78, 95% ci: 0. 56-1. 00). Following surgery, 86. 5% of the patients presented with useful facial function (house-brackmann grades i-iii). Correct simulation of the fn did not prevent postoperative facial palsy (p
0. 35). Conclusions. The accuracy of dti-ft of the fn integrated with neuronavigation remains unsatisfactory. This method does not provide any clinical benefit over non-integrated dti-ft in terms of nerve function preservation. Clinical implications. Due to the low reliability of the predictions, further technical advances inpredicting the course of the fn are awaited by clinicians. However, dti-ft images in the operating theatre would make tumour excision more comfortable for the surgeon. Reported events: 14 patients experienced a surgery-related facial palsy. 4 patients experienced post-operative cerebrospinal fluid (csf) leakage, which was treated successfully by external lumbar drainage.
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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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key10672834
MDR Text Key215886552
Report Number1723170-2020-02697
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9733858
Device Catalogue Number9733858
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 Received10/13/2020
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: 10/13/2020 Patient Sequence Number: 1