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

Model Number TPL0059

Device Problems Electrical /Electronic Property Problem (1198); Malposition of Device (2616)

Patient Problems Pain (1994); Tissue Damage (2104)

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

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 3define failed during the procedure.A second 3define was successful.Registration was performed quickly.Upon instrumenting first trajectory (left l4), the workstation beeped and gave an instruction to lock the arm in the software.The surgeon did not have tools in the arm guide when this notification occurred.The arm was relocked in the software and another 3define was performed.The 3define failed again on the first attempt.The second attempt for 3define was successful.Registration was performed quickly, and surgeon instrumented all 4 trajectories.Ap and lateral x-ray images verified wires were accurately placed.Two days following the case, the rep received notification that the right l4 screw had been misplaced lateral and superior.Revision procedure was scheduled for saturday (b)(6) 2019 to remove screw and place new one.It was also noted that the workstation would not allow import or export of any data.The patient complained of right leg pain post operatively.Additional information received from the rep indicated that the screw inaccuracy was greater than 3.5mm but less than 10mm.The patient's symptoms had resolved after the successful revision surgery on (b)(6) 2019.There were no additional complications reported or anticipated as a result of the event.

Manufacturer Narrative

Analysis of the clinical export files found the suspected cause of the reported deviations was sub-optimal planning of the right l4 screw, resulting in a possible lateral-superior skiving of the tools.An accurate trajectory was drilled after the deviated one.The k-wires placed using the guidance system were found to be deviated, slightly superior, but still inside of the pedicle.A lateral deviation could not be confirmed.If information is provided in the future, a supplemental report will be issued.

• 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: 8602351
• MDR Text Key: 144796610
• Report Number: 1723170-2019-02279
• 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,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 91