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

Model Number BI70000027100

Device Problem Imprecision (1307)

Patient Problem Tissue Damage (2104)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging system.It was reported that during a sacroiliac and thoracolumbar (lower/mid spine) there were issues with screw placement and there were not enough extenders.Percutaneous pedicle screw (pss) fixation was performed with "e5" using an imaging system and a navigation system.Fixation was performed at "th3/8" (interpreted as thoracic vertebrae level 3 through 8).(because left pedicle of th5 was fractured, so it was skipped.) a total of eleven screws were scheduled to be inserted, but there were only eight e5 extenders.Therefore, with the imaging system navigation, five screws on the left side and screws on the right side at th4 and th6 were inserted, and a distraction force by the trauma device was applied to the fractured vertebral body th5.On the left side, rods and plugs were placed and final tightening was performed, and the trauma device and extender were removed.After that, images were taken by the imaging system with the extender upright at th4 and th6 on the right side, and t he remaining screws were inserted under the navigation.When images were taken again by the imaging system to check for screw deviation, the th5 and th7 screws (the defective products this time) had deviated inward.Inserting the screws again was attempted, but the pilot hole was already loose, so the rod was placed and final tightening was performed without implantation and the procedure was completed.There was a delay to the procedure of less than one hour.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative (confirmed via healthcare provider) indicated the th5 and th7 pedicle screws on the right side deviated toward the spinal canal.There was no alleged issue with the screws.The screw deviation was clarified to be an inaccuracy of approximately 2 to 2 mm.The patient reference frame was reportedly placed in th3.There was the possibility the screw deviation was due to inaccuracy or the patient anatomy.Furthermore, there was no possibility that the spine stability issue was due to not having the expected amount of extenders.

Manufacturer Narrative

H3: a software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• MDR Report Key: 9275298
• MDR Text Key: 167345813
• Report Number: 3004785967-2019-01914
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2020

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: No Information
• Device Model Number: BI70000027100
• Device Catalogue Number: BI70000027100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 11/10/2019; 11/10/2019
• Supplement Dates FDA Received: 12/05/2019; 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention