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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number UNK_NAV_SYS
Device Problem Imprecision (1307)
Patient Problems Muscle Weakness (1967); Unspecified Tissue Injury (4559)
Event Date 06/05/2021
Event Type  malfunction  
Manufacturer Narrative
Patient age is the mean value of patients in the study. Patient gender is the majority value of patients in the study. Patient weight not available from the site. Event date is the online publishing date of the literature article. Device lot number, or serial number, unavailable. 510(k) is dependent upon the device model number and is therefore, unavailable. No parts have been received by the manufacturer for evaluation. Device manufacture date is dependent on the device lot/serial number, therefore is unavailable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Citation: masato tanaka, venkatesh kadiri, sumeet sonawane, koji uotani, shinya arataki, yoshihiro fujiwara, yoshiaki oda , taro yamauchi, tomoyuki takigawa. Comparative evaluation of screw accuracy and complications of new c-arm free o-arm navigated minimally invasive cervical pedicle screw fixation (miceps) with conventional cervical screw fixation. Interdisciplinary neurosurgery: advanced techniques and case management 25 (2021). Https://doi. Org/10. 1016/j. Inat. 2021. 101278 abstract: study design: retrospective comparative study. Objective: comparative study of c-arm free o-arm navigated minimally invasive cervical pedicle screw (miceps) fixation with conventional cervical pedicle screw fixation. Methods: twenty-five patients with different cervical spine pathologies were operated with miceps with o-arm navigation (group m; 18 patients) and conventional pedicle screw (group c; 7 patients) from june 2017 to january 2020. Operative time, blood loss were recorded. Preoperative and postoperative radiograms, ct scans and mri were evaluated. Postoperatively screw position accuracy and angulation was determined on ct. Breach rate was evaluated on ct scan and classified according to neo grading. Complications if any were noted. Results: the average blood loss in group m and group c was 129 ml and 329 ml, respectively. The average operative time in group m and group c was 77. 4 min and 82. 3 min, respectively. A total of 148 screws were inserted. In group m, no patient showed grade 2 and 3 breach while in group c, grade 0 and 1 breach was found in 85. 7% screws and grade 2 in 14. 3% screws. Mean screw medial angulation was 45. 2 degrees in group m and 33. 4 degrees in group c. There was one dural tear and two c5 palsies in each group. Conclusion: with c -arm free o-arm navigated miceps fixation operative time and blood loss are less though not statistically significant. It has less pedicle breach rate, less incidence of neurovascular complications than conventional technique. There is no radiation exposure to operating surgeon and staff. Complications: one patient experienced a dural tear that healed without consequences 2) two patients experienced a c5 palsy that recovered after two months. 15. 1% of screws were found to have a non-significant grade 1 breach.
 
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Brand NameMEDTRONIC NAVIGATION
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12410332
MDR Text Key269507761
Report Number1723170-2021-02188
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
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 09/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/01/2021
Is this an Adverse Event Report? No
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 Received08/26/2021
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

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