MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9733856 S7 STAFF ASSEMBLED 110V; INSTRUMENT, STEREOTAXIC

Model Number 9733856

Device Problem Imprecision (1307)

Patient Problem Neuropathy (1983)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

No parts have been returned for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used in a sacroiliac and thoracolumbar procedure.It was reported that towards the end of the case the nerve monitoring was not responding anymore.The health care professional was accurate at the beginning of the case and throughout.After rods and 6 screws were placed, however the last one was found to have breached the spinal canal, this was seen after taking a confirmation spin.At this point navigation was aborted causing less than an hour delay in the procedure.A c-arm was used in conjunction with the o-arm during the case.The patient was affected.Additional information was received.The rep contacted the site.It was confirmed that there was not an inaccuracy.The site stated anatomical landmarks were checked and accuracy was confirmed by the physician throughout the case.The surgeon mentioned to the neuro coordinator that the patient had very poor bone quality as a result of metastatic bone disease.

• Brand Name: CART 9733856 S7 STAFF ASSEMBLED 110V
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8436634
• MDR Text Key: 139332241
• Report Number: 1723170-2019-01228
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2014
• 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: 82 YR
• Patient Weight: 69