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

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).

• Brand Name: STEALTHSTATION TREON NAVIGATION CART, SHORT
• Type of Device: NEUROLOGICAL 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 Key: 6246026
• MDR Text Key: 64657008
• Report Number: 1723170-2017-00133
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• 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 Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: TREON SHORT POLE
• Device Catalogue Number: 9730022
• 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 Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2006
• 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