MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® SPINE REFERENCING SET; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	9730605
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The small reference frame was returned to the manufacturer for analysis.Analysis found that the starburst adapter was loose on the back of the frame.One of the screws was stripped and falling out.Analysis found that the reported event was related to a physical damage issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that a spine reference frame was broken during surgery.The frame adapter was held in place for the remainder of the procedure which steri-strips.There was no impact to patient.There was no reported delay to the procedure due to this issue.

• Brand Name: STEALTHSTATION® SPINE REFERENCING SET
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville 80027 ; CO 80027
• MDR Report Key: 8108572
• Report Number: 1723170-2018-05885
• Device Sequence Number: 13959766
• Product Code: MAX
• UDI-Device Identifier: 00721902812743
• UDI-Public: 00721902812743
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2018

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: 120524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 84