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 Impaired Healing (2378); Iatrogenic Source (2498)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

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.Per the journal article, 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.After review of the journal article and based on clinical knowledge, nonunion (failed to heal) can have many causes.This is a fixation after a cervical trauma.Causes can be related to excessive motion, suboptimal alignment of the fusion, poor bone placement in fusion area, etc.Asymptomatic do not require treatment/intervention.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 attached journal article was forwarded by a medtronic representative.Use of the imaging and navigation system was reported.This is medical device report (mdr) two of two.See 1723170-2017-04507 for first 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)-old man with a history of an atv accident presented with neck pain.The patient was taken for imaging and navigated anterior odontoid fixation.A postoperative cervical radiograph showed nonunion, and minimal displacement.His neck pain had resolved and the patient remained asymptomatic.The follow up was 10 months.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: 7007421
• MDR Text Key: 91287909
• Report Number: 1723170-2017-04508
• 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

• 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
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 11/07/2017
• 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
• Patient Age: 40 YR