MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC REFERENCE FRAME SMALL PASSIVE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	9730605
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided at the time of report.The returned frame is well worn.The attachment screw threads are also worn down causing the reported issues.If the mating screw is aligned perfectly, attachment is easy.However, if the alignment is not just right it causes the reported difficulty.Otherwise, with markers attached and fully seated, the frame displays good geometry and divot error readings with normal tracking.H6 10,180,4307 are associated with device return and analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system that was used during a sacroiliac and thoracolumbar procedure.It was reported that the engagement of open spine clamp and reference frame was poor.It was also stated the "spine clamp and frame could not be fasten smoothly." the open spine clamp was not attached to the reference frame well.The procedure was completed with the continuous use of the navigation system.There was a reported delay of less than one hour.There is no known impact on patient outcome.It was reported that "engagement of open spine clamp and reference frame was poor" means ¿the open spine clamp was not attached to the reference frame well¿.

• Brand Name: REFERENCE FRAME SMALL PASSIVE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10556684
• Report Number: 1723170-2020-02477
• Device Sequence Number: 3528468
• Product Code: MAX
• UDI-Device Identifier: 00721902812743
• UDI-Public: 00721902812743
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2020

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 Expiration Date: 03/22/2014
• Device Model Number: 9730605
• Device Catalogue Number: 9730605
• Device Lot Number: 090904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1