MAUDE Adverse Event Report: MEDTRONIC NAVIGATION INST 9730605 FRAME REF SM PASSIVE SP; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	9730605
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been returned for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
2020-6-15 (b)(4) (rep for):medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the frame was not visible.If the frame was visible then the instrument would verify but would be inaccurate or up to 5mm.Other small passive frames were working as intended.There was noted to be something bent on the frame.
Additional Manufacturer Narrative
H3) the passive frame was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was not confirmed.The surface of the returned frame was very worn with most of the color gone, but the frame was in otherwise good working condition.With markers attached and fully seated, the frame displayed good geometry and divot error readings with normal tracking.No problem found.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: INST 9730605 FRAME REF SM PASSIVE SP
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC NAVIGATION; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10206834
• Report Number: 1723170-2020-01784
• Device Sequence Number: 2404597
• Product Code: MAX
• UDI-Device Identifier: 00721902812743
• UDI-Public: 00721902812743
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9730605
• Device Catalogue Number: 9730605
• Device Lot Number: 140123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1