• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Muscle Weakness (1967); Neurological Deficit/Dysfunction (1982); Seizures (2063)
Event Date 10/20/2019
Event Type  Injury  
Manufacturer Narrative
Age: patient age is the mean value of patients in the study. Sex: patient gender is the majority value of patients in the study. Weight: patient weight not available from the site. Date of event: event date is the accepted date of the publication. Device lot number, or serial number, unavailable. Pma/510(k): 510(k) is unavailable as the value is dependent on the model number of the product. Device evaluated by manufacturer: no parts have been received by the manufacturer for evaluation. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. (b)(4). If information is provided in the future, a supplemental report will be issued.
Event Description
Citation: soumya mukherjee, joseph wood, imran liaquat, simon r. Stapleton, andrew j. Martin. Craniotomy for recurrent glioblastoma: is it justified? a comparative cohort study with outcomes over 10 years. Clinical neurology and neurosurgery 188 (2020) 105568. Https://doi. Org/10. 1016/j. Clineuro. 2019. 105568 abstract: objective: the role of repeat resection for recurrent glioblastoma multiforme (rgbm) is unclear. This large comparative cohort study assessed overall survival (os), survival since recurrence (ssr), quality of life, and complications in reoperated versus non-reoperated patients for rgbm. Patients and methods: all patients with rgbm between 2005 and 2015, who were discussed by our institution¿s multi-disciplinary team, and who either did or did not undergo reoperation, were prospectively followed up with data collected and compared. Survival and prognostic factors were analysed using kaplan¿meier and cox regression methods. Results: 312 patients (reoperated, n
145; non-reoperated, n
167) were analysed. Median ssr was 10. 8 months and 6. 9 months in the reoperated and non-reoperated groups respectively (log-rank test: p
0. 02). Median os was 24. 1 months and 20. 4 months in the reoperated and non-reoperated groups, respectively (logrank test: p
0. 04). Quality of life as measured by short form 36 scores were 59 versus 54 at baseline and 62 versus 51 at four-month follow-up for re-operated and non-reoperated groups, respectively (p < 0. 05). Age < 60 years, karnofsky performance status (kps)
80, recurrence
9 months from initial diagnosis, methylguanine methyltransferase (mgmt) promoter methylation, and extent of resection (eor)>80 %, each were significant predictors of ssr and os. Complication rates were 5. 5 % and 6. 2 % following repeat resection and primary resection, respectively (p > 0. 05). Conclusion: this is the first large prospective comparative cohort study of rgbm and demonstrates that repeat resection confers a small but significant benefit in survival and quality of life over non-operative treatment. Best prognosis is associated with: younger age, kps
80, late recurrence, mgmt promoter methylation and eor > 80 %. Reported events: 1) four patients in the repeat resection cohort experienced infections. A. One infection was reported to require additional surgery where the bone flap was removed. 2) two patients in the repeat resection cohort experienced seizures. 3) one patient in the repeat resection cohort experienced muscle weakness. 4) one patient in the repeat resection cohort experienced speech deficits.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10171396
MDR Text Key198895691
Report Number1723170-2020-01701
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 06/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
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 Received06/02/2020
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: 06/18/2020 Patient Sequence Number: 1