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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION TREON NAVIGATION CART, SHORT NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION TREON NAVIGATION CART, SHORT NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TREON SHORT POLE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Unspecified Infection (1930); Spinal Column Injury (2081); Iatrogenic Source (2498)
Event Date 06/29/2016
Event Type  Injury  
Manufacturer Narrative
Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's stealthstation treon treatment guidance system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event. Reported patient events are known inherent risks to this procedure type due to complex anatomy. The article concludes that using iso-c 3d navigation can improve accuracy of the c1¿c2 transarticular screws, decrease intra-operative fluoroscopic time and blood loss, and not prolong the operative time. This study demonstrates that iso-c 3d navigation is a safe and effective means of guiding c1¿c2 transarticular screw fixation for atlantoaxial instability.
 
Event Description
Per the attached journal article, isocentric c-arm three-dimensional navigation versus conventional c-arm assisted c1¿c2 transarticular screw fixation for atlantoaxial instability by yang et al: between (b)(6) 2006 and (b)(6) 2013, 42 patients diagnosed with atlantoaxial instability were treated with c1¿c2 dorsal transarticular screw fixation (magerl¿s technique). Patients were assigned to two different groups depending on their requirements. Twenty-four patients were operated with conventional c-arm fluoroscopy. During the same time period, the iso-c 3d fluoroscopy and computer navigation system were used in the other 18 patients with the identical surgical implants. Insertion was considered correct if the screw passed through the atlantoaxial joint to the anterior cortex of the atlas without perforation to the cortex of the atlantoaxial joint. Fusion was defined by a lack of motion on flexion¿extension plain radiographs and bridging trabecular bone between the graft and c1¿c2 on ct scans [17]. Screw position of the screws was divided into three grades: grade 0 (ideal placement): screw completely within the bone cortex; grade 1 (acceptable placement): less than 50 % of the diameter of the screw enters the surrounding cortex and less than 5 mm protrudes from the anterior cortex for transarticular screws; grade 2 (unacceptable placement): clear violation of transverse foramen or spinal canal, regardless of clinical neurovascular complications [18]. In the iso-c 3d group, one patient was scanned three times because of malposition of k-wires. Overall, 97. 2 % (35/36) of screws placed using iso-c 3d fluoroscopy were assessed as grade 0. One screw was grade 1. This screw breached into the spinal canal. No nervous deficit was detected in this patient. One superficial tissue infection was reported in the navigated group. It was treated with sensitive antibiotics and dressing change, rather than debridement. Pelvic hematoma was found in one patient of the iso-c 3d group and cleared 7 days postoperatively. No procedure-related deaths were identified in all cases. No newly developed neurologic deficits occurred after surgery. Neither spinal cord injuries nor spinal nerve root injuries were observed postoperatively. Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's stealthstation treon treatment guidance system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event. (b)(4).
 
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Brand NameSTEALTHSTATION TREON NAVIGATION CART, SHORT
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
peter verhey
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902092
MDR Report Key6246026
MDR Text Key64657008
Report Number1723170-2017-00133
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 05/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTREON SHORT POLE
Device Catalogue Number9730022
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/10/2006
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: 01/12/2017 Patient Sequence Number: 1
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