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

Model Number TPL0038

Device Problem Data Problem (3196)

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

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

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 there was a deviation on l5 on the right side and deviations on l4 and l5 on the left side.One screw was accurate and three were misplaced.No revisions were complete.No additional information was able to be retrieved from the facility.

Manufacturer Narrative

Clinical export data files were inspected and after eliminating planning and registration shifts, the investigating team has reviewed all available information and concluded the root cause of the deviations to be patient movement/shift, as all trajectories were deviating in the same manner.If information is provided in the future, a supplemental report will be issued.

• Brand Name: N/A
• Type of Device: INSTRUMENT, STEREOTAXIC
• 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: 9484525
• MDR Text Key: 177383849
• Report Number: 1723170-2019-06064
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

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: TPL0038
• Device Catalogue Number: TPL0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 01/19/2020
• Supplement Dates FDA Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 88