MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PROBE LUMBAR STEREOTAXIC INSTRUMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734402
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been returned to the manufacturer for evaluation.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.There was no patient present.It was reported that the instruments had been damaged.

• Brand Name: PROBE LUMBAR STEREOTAXIC INSTRUMENT
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8207381
• Report Number: 1723170-2019-06513
• Device Sequence Number: 19336720
• Product Code: OLO
• UDI-Device Identifier: 00613994724021
• UDI-Public: 00613994724021
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/01/2019

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: 9734402
• Device Catalogue Number: 9734402
• Device Lot Number: 120803
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 01/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1