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

Model Number	9730605
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Part has not been returned for analysis.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 outside of a procedure.It was reported that the spine reference had a defect and was unusable.There was no patient present when this issue was observed.
Additional Manufacturer Narrative
Additional information: it was reported that the sites navigation system couldn¿t track the spine clamp.There was no obvious damage visible but a second spine clamp worked normally.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INST FRAME REF SM PASSIVE SP
• 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: 8117522
• Report Number: 1723170-2018-05947
• Device Sequence Number: 193665
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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?: No
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1