MAUDE Adverse Event Report: SANMINA -SCI SYSTEMS O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	BI70002000
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	07/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
*this event was also reported for the navigation system under report #255106150.* if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding an imaging system being used during a minimally invasive spinal procedure on t11-l1.It was reported that the site registered a driver, and used a needle for the first incision, entry point, and guide wire placement.The site did the top level screws first, and then went to the lower level.The navigation indicated that the needle was completely in the pedicle, as was the driver.The site did the post op spin, and found that the lower level screws were completely out on both sides.Both screws were deviated by 15mm, but one was lateral, and the other was medial and through the canal.The site then tried to navigate off the second spin, however they were very doubtful of it's integrity.The screw trajectory was checked by placing a blue probe behind the crew head.The navigation system showed that the entry point was fine and that the trajectory was fine, but the post op spin still showed that the screws were off.Navigation was aborted to perform the surgery as a full open spinal surgery.The procedure was delayed one hour or longer.
Additional Manufacturer Narrative
Section d information references the main component of the system.Other relevant device(s) are: product id: bi-500-01065, version 4.1.0 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.
Event or Problem Description
Additional information was received and it was noted that all four screws were not accurately placed.Additionally, two automatic re gistrations were performed on the primary navigation image acquisition and implant verification acquisition.It was noted that the reference frame was placed on the t9 vertebrae".
Additional 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.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.
Additional Manufacturer Narrative
H2: additional information was received.B5 has been updated.H2/h3/h6: the system was serviced in the field.Software analysis completed and was unable to determine the probable cause of the issue and if it relates to software anomaly based on the review of the information documented on record.An analysis of the dicom images did not find obvious issues, except the metal region get saturated at certain slices.The review of the image information for the four fluoro images found they were taken at different kvps but all of the x-ray tube current showed 6ma.The system log review and image data review was found to be inconclusive.This case may be re-opened if additional information is received.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.
Event or Problem Description
Additional information was received.It was reported that after re-assessment of the patient scans and after testing the integrity and accuracy of the imaging and navigation systems, it was believed that the cause was user error.It was noted that several things can lead to inaccuracies and that it can be hard to pin point the cause.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SANMINA -SCI SYSTEMS; km 15.5 no. 29, plant 06; carr. chapala-guadalajara,jal 45640 ; MX 45640
• MDR Report Key: 10251865
• Report Number: 3006544299-2020-00239
• Device Sequence Number: 2864897
• Product Code: OWB
• UDI-Device Identifier: 00763000134518
• UDI-Public: 00763000134518
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/02/2020

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
• Operator of Device: Health Professional
• Device Model Number: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 07/16/2020; 07/10/2020; 08/19/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 07/17/2020; 08/03/2020; 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR
• Patient Weight: 70