MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. NAVLOCK¿; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734680
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was putting a pedicle screw in the spine when the medtronic navigation probe tip broke inside the pedicle.Surgeon attempted to remove and was unable to.Surgeon felt risks outweighed the benefit, and tip was left in.

• Brand Name: NAVLOCK¿
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; ms ss-54; louisville CO 80027
• MDR Report Key: 15327046
• Report Number: 15327046
• Device Sequence Number: 15074315
• Product Code: OLO
• UDI-Device Identifier: 00763000054205
• UDI-Public: (01)00763000054205
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/16/2022
• Report Date (Section F): 08/16/2022

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: 9734680
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/31/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/16/2022