MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MAZOR X SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number TPL0059

Device Problem Malposition of Device (2616)

Patient Problem Spinal Cord Injury (2432)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

Evaluation of the returned export file concluded the root cause of the deviation experienced in the operating room was a platform shift due to an unstable platform.The platform was subject to extreme soft tissue pressure, which might have contributed to the platform instability.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a guidance device being used in a spinal procedure.It was reported that there were 3 misplaced screws with canal breeches and dural tears.It was noted that extreme soft tissue pressure and poor technique lead to the event.It was noted that the navigation did not depict the deviations true as they overlaid the arm trajectory and gave a false sense of security.It was noted that the surgery was completed with free hand navigation.Additional information received from the rep indicated that the screw placement was 10-11mm midline.Contributing factors to the technique issues included a deep big patient and lots of tissue pressure.Microscope and suture to repair tears was done to resolve the dural tears.There were no additional complications reported or anticipated as a result of the event.

• Brand Name: MAZOR X SYSTEM
• 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: 8619586
• MDR Text Key: 145371346
• Report Number: 1723170-2019-02402
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163221
• 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
• Report Date: 05/17/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 59 YR