MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Iatrogenic Source (2498); Blood Loss (2597)

Event Date 10/08/2014

Event Type  Injury  

Manufacturer Narrative

Patient identifier was not provided by the journal article surgeon/author. Patient age and sex were not made available. This number addresses the 9 males and 8 females in this study. The median age was 47. 6 years (range 22-78 years). Patient weight was not provided by the journal article surgeon/author. The events were reported to have occurred approximately around august 2011 to august 2013, when the cervical fixation procedures were completed. The article was accepted on 10/8/2014. Further information was not provided by the authors. Citation: francesco costa, md, alessandro ortolina, md, luca attuati, md, andrea cardia, md, massimo tomei, md, marco riva, md, luca balzarini, md, and maurizio fornari, md. Management of c1¿2 traumatic fractures using an intraoperative 3d imaging¿based navigation system. J neurosurg spine (2015). Http://thejns. Org/doi/abs/10. 3171/2014. 10. Spine14122. The journal article states that, "fixation of c1¿2 is a challenging surgical procedure because of the anatomical characteristics of the two vertebrae. Screw insertion into cervical pedicles, lateral masses, laminae, or the dens remains challenging, especially in cases of traumatic fractures where the anatomy has been altered. The journal article confirms: in summary, spinal navigation in the management of c1¿2 fractures is a feasible and safe technique when performed using the imaging system. However, even if great effort is made to achieve good results with the imaging system, we want to stress that this technology cannot completely eliminate all risks associated with spinal instrumentation, and the experience and skill of the surgeons remain essential determining factors. Customer has not requested service for the system regarding this event. No parts have been returned for analysis. Literature review.

Event Description

A medtronic representative reported an event that was identified in the attached journal article. Fractures of c-1 and c-2 are complex and surgical management may be difficult and challenging due to the anatomical relationship between the vertebrae and neurovascular structures. The aim of this study was to evaluate the role, reliability, and accuracy of cervical fixation using the imaging system intraoperative 3d image¿based navigation system. From august 2011 to august 2013, patients sustained traumatic fractures of c-1 and/or c-2. Of this population 17 patients (73. 9%) underwent cervical fixation; these 17 patients form the basis of the study. The population comprised 9 males (52. 9%) and 8 females (47. 1%), whose median age was 47. 6 years (range 22¿78 years). During this study, no intraoperative complication such as injury of the (b)(6), spinal nerve root, or spinal cord was recorded. Two patients received a blood transfusion during surgery to manage venous bleeding of the c-1 plexus. The postoperative course was uneventful in all patients except in one patient who developed a superficial wound infection 10 days after surgery, which was treated with surgical debridement and antibiotic therapy. Satisfactory radiological fusion signs were assessed in 15 patients (88. 2%). One patient had signs of bony resorption around the screws placed in c-2 documented on control radiographs and confirmed on ct performed at the 5 month-follow-up; the study, however, showed initial signs of fusion between c-1 and c-2 due to the iliac crest graft. Clinically, the patient did not complain of any pain or limitation; in this case the treatment was conservative (use of cervical brace). During the follow-up period) mean 15. 2 months, range 5-29 months) 16 patients (94. 1%) exhibited a favorable clinical recovery (defined as a denis grade of p1 or p2 [no pain or occasional mild pain not requiring medication, respectively]), and only 1 patient required occasional medication for moderate pain (denis grade of p3). The mean surgical radiation dose received by the patient was 1. 83 msv, while the dose per surgery received by the surgeon performing the imaging acquisition (protected behind a lead wall) at breast level was 0. 01 msv. In summary, spinal navigation in the management of c1¿2 fractures is a feasible and safe technique when performed using the imaging system. However, even if great effort is made to achieve good results with the imaging system, we want to stress that this technology cannot completely eliminate all risks associated with spinal instrumentation, and the experience and skill of the surgeons remain essential determining factors. Other patient events mentioned in the attached article are reported in mdr 1723170-2016-05791, 1723170-2016-05792, 1723170-2016-05793, 1723170-2016-05794 and 1723170-2016-05795. It is unclear if the patients mentioned in this report are any of the same patients in these other reports as specific patient demographics were not provided.

Manufacturer Narrative

The reported issue was reviewed by medtronic personnel. The ifu (per (b)(4) rev 12 pg 30 and 52) which accompanies this device contains the following warnings regarding frame movement: "warning: make sure that the reference frame assembly is rigidly attached and locked (tightened) with respect to the relevant anatomy. If the post or clamp moves in relation to the anatomy, navigational inaccuracy may result. ¿ and ¿warning: do not bump or reposition the reference frame after registration. Such movement may result in inaccurate navigation. If the reference frame moves in relation to the patient anatomy at any time after registration, you must reregister. ".

• Brand Name: STEALTHSTATION S7 SYSTEM
• 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
• MDR Report Key: 6196753
• MDR Text Key: 63061519
• Report Number: 1723170-2016-05796
• 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
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: S7
• Device Catalogue Number: 9733858
• 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: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2011
• 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: 12/21/2016 Patient Sequence Number: 1