MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PAK NAV NIM-SPINE PEDICLE ACC KT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9733497
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Iatrogenic Source (2498)
Date of Event	10/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device lot number not available as the part was discarded at the site.Device manufacturing date is dependent on lot number, therefore, unavailable.This part was discarded by the site and will not be returned to manufacturer for analysis.A medtronic representative, following-up at the site, reported the pak needle never malfunctioned, rather it was not long enough for what the surgeon desired.Report noted to be a feature request.There was no allegation the device malfunctioned.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's pak navigated spine pedicle needle.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.
Event or Problem Description
A medtronic representative reported that, while in a minimally invasive spine procedure, the surgeon alleged being unable to track their pedicle access kit (pak) needle because it was too far down into the patient.The surgeon found the pak needle could not be tracked at the angle he was using.The surgeon placed a screw too laterally in l3, performed another spin and repositioned the screw.The pak needle never malfunctioned, rather it was not long enough for what the surgeon desired.The surgeon completed the procedure with the use of the navigation.Delay in therapy was less than one hour.Report noted to be a feature request.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's pak navigated spine pedicle needle.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.
Additional Manufacturer Narrative
The feature request was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: PAK NAV NIM-SPINE PEDICLE ACC KT
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6073969
• Report Number: 1723170-2016-02780
• Device Sequence Number: 10777877
• Product Code: OLO
• UDI-Device Identifier: 00613994475152
• UDI-Public: 00613994475152
• 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: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Catalogue Number: 9733497
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2016
• Supplement Report FDA Received Date: 01/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 98