MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) UPGRADE PRGM 9734261 STEALTHSTATION S7; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

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

Patient Problems Dysphagia/ Odynophagia (1815); Bone Fracture(s) (1870); Hematoma (1884); Iatrogenic Source (2498)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

Specific patient identifier not made available by the journal article author.Patient labeled as case no.8 and therefore used.Patient weight not made available by the journal article authors.Event date is approximated.Date provided is when the journal article was accepted.The exact system information could not be determined as it was not provided.However, the system listed on this form was at the address listed in the article during the time some of the surgeries were completed and suspected to be the system used for the procedures.Citation: j.M.Pisapia et al.J neurosurg spine 26:10¿18, 2017.Published online august 12, 2016; doi: 10.3171/2016.5.Spine151412.Multiple attempts have been made to obtain additional information.No further information provided in the journal article or from the authors.No request for service have been received from the customer regarding these events.No parts have been replaced or returned to the manufacturer for evaluation.After review of the journal article and based on clinical knowledge, the hematoma experienced by the patient could be due to the procedure or the multiple falls (trauma) experienced prior to procedure.The follow-up displacement the patient experience maybe be related to the additional falls this patient experienced.However, no additional information was provided by the authors.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic imaging navigation system.There is no allegation to suggest that medtronic device caused or contributed to the reported event.

Event Description

The journal article was forwarded by a medtronic representative.Use of the imaging and navigation system was reported.This is medical device report (mdr) one of two.See 1723170-2017-04508 for second mdr.The authors present in a stepwise fashion the technique of odontoid screw placement in cervical spine fractures using the medtronic imaging and navigation system and describe their initial institutional experience with this surgical approach.Retrospective review was between 2006 and 2015.A (b)(6)-year-old man with a history of multiple falls from standing presented to the emergency department with neck pain.Ct of the cervical spine showed a nondisplaced type ii odontoid fracture.The patient was taken for navigated anterior odontoid fixation.A postoperative cervical radiograph showed good screw position.Three days after surgery, the patient developed right-sided neck pain and dysphagia.A ct scan of the neck showed a neck hematoma, and the patient was taken for surgical evacuation of the hematoma.He remained without neurological deficit.At the 1.5-month follow-up, he returned after several falls with severe neck pain.A ct scan showed a displaced fracture of c-2 with the odontoid screw partially extruded into the prevertebral soft tissues anterior to c-3.He was taken for odontoid screw removal and uncomplicated occipitocervical instrumented fusion.His neck pain had improved but was still present 2 months after most recent surgery.For the success of all of surgical techniques used for cervical spine fractures, accurate and safe screw placement is required, but this can be difficult in the setting of trauma.The authors reported that using the imaging with navigation for anterior odontoid screw fixation may offer potential benefits compared with free-hand and fluoroscopy-based techniques.For the patient, advantages of the imaging and navigation system include increased accuracy of screw placement, and the ability to perform an intraoperative ct to confirm the location of screw placement.Another advantage is that based on distortion of bony anatomy due to fracture, the trajectory can be altered during the procedure as well.Per the author's, although the use of navigational adjuncts can help to guide screw placement and avoid injury to surrounding structures, rates of screw misplacement are not reduced to zero.Thus, the imaging and navigation system is meant to complement screw placement technique and is not a substitute for an intimate understanding of surgical anatomy or surgeon experience.

• Brand Name: UPGRADE PRGM 9734261 STEALTHSTATION S7
• 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: oksana ditolla ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7007419
• MDR Text Key: 91288561
• Report Number: 1723170-2017-04507
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9734261
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 77 YR