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

Model Number 9736060

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Device manufacturing date, unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that during a revision case where they were adding l2 and l5 to an existing construct, there were issues tracking the blue and black navlocks and the robotic reference frame.They were tracking intermittently.The representative had the spheres replaced and verified they were snapped into place.There was no line of site issues.The representative moved or lights away as well.When the instrument was tracked it was showing up in the middle of the near/far tracking range under tracking details.The representative checked the geometry error and it was resting at.35 -.45 when the instrument was facing the camera straight on.No patient harm was reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative reported that they did determine that the problem was not with the reference frame or any of the navlocks but rather was caused by interference from the surgeons camera headlight.When the surgeon stared at the surgeon tablet, they found that the instruments and reference frame would disappear from the tracking view, however, when he looked away, they would reappear.The problem only occurred when using that particular headlight.Since the issue was determined to not reside with the devices, they have not been returned for analysis.

Manufacturer Narrative

Additional information: patient information updated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NAVLOCK TRACKERS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9700282
• MDR Text Key: 183793373
• Report Number: 1723170-2020-00480
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2020

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
• Device Operator: Health Professional
• Device Model Number: 9736060
• Device Catalogue Number: 9736060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 03/24/2020; 03/24/2020
• Supplement Dates FDA Received: 04/14/2020; 04/14/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 87