MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number BI70000028120

Device Problem Poor Quality Image (1408)

Patient Problem Tissue Damage (2104)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.It was reported that the issue could not be confirmed or replicated, no components were replaced.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that, while in a spinal fusion, an imprecision was noted with the imaging system.There was no reported delay to the procedure due to this issue.There was no reported impact on patient outcome.It was reported that four image acquisitions from each side of the table were conducted with saw bones and multiple nipple markers.It was noted that all image acquisitions were accurate on the imaging system.Additional information indicated the image acquisitions were performed on the following day after the procedure.The procedure was minimally invasive, so it was not known until the next day that the screws were misplaced.At that time, the patient was brought back to the operating room and screws were replaced with the use of navigation.The screw placement was then confirmed with a post-operative image acquisition.There were no unused images and no numerical value for inaccuracy.Following the screw replacement procedure, the surgeon mentioned the reference may have moved during the procedure.

• Brand Name: O-ARM 1000 IMAGING SYSTEM 3RD EDITION
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8907539
• MDR Text Key: 154778909
• Report Number: 3004785967-2019-01473
• Device Sequence Number: 1
• Product Code: OXO
• UDI-Device Identifier: 00643169353428
• UDI-Public: 00643169353428
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092564
• 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: 08/19/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: BI70000028120
• Device Catalogue Number: BI70000028120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2014
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 100