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

Model Number TPL0059

Device Problem Mechanical Jam (2983)

Patient Problems Iatrogenic Source (2498); No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2019

Event Type  Injury  

Manufacturer Narrative

System check out was performed and confirmed the event.The shoulder piston sensor was moved to the correct location and secured.The system passed all checks and tests.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 shoulder will not lock via physical button or software button.It was noted there was no patient harm but the case was aborted.There were no additional complications reported or anticipated as a result of the event.

Manufacturer Narrative

Additional information received indicated that there was no adverse event or reportable product problem.Additional information received indicated there was no outcome attributed to an adverse event.Additional information received indicated that there was no serious injury, death, or reportable malfunction.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the rep indicated that when the shoulder would not lock, the mazor x part was aborted.The case still took place.

• 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: 8680462
• MDR Text Key: 147383999
• Report Number: 1723170-2019-03080
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

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
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 06/12/2019
• Supplement Dates FDA Received: 07/10/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other