MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC N/A; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734680
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the tip of the probe is visibly bent.There are also impact marks at the back end causing fit issues with a mating tracker.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system while in a sacroiliac and thoracolumbar procedure.It was reported that the tip of the navlock thoracic probe was bent.The procedure was complete with the use of navigation.There was a delay of less than 1 hour.No known impact on patient outcome.

• Brand Name: N/A
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8727185
• Report Number: 1723170-2019-03766
• Device Sequence Number: 16576476
• Product Code: OLO
• UDI-Device Identifier: 00613994870063
• UDI-Public: 00613994870063
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2019

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: No Information
• Device Model Number: 9734680
• Device Catalogue Number: 9734680
• Device Lot Number: 160830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 06/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1