MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SPINOUS PROCESS CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9734716

Device Problem Output Problem (3005)

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

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation has not been done at the time of submitting this report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during a sacroiliac and thoracolumbar procedure.It was reported that the spinous process clamp moved.They were working on the last level, l5, and noticed that the clamp had moved.They checked their accuracy and decided to finish the case with a c-arm.Troubleshooting was done by the clinical specialist (cs) that was onsite and there were no issues with the clamp remaining engaged.It was believed that it was attached to soft tissue that allowed it to shift.There was a procedure delay of less than one hour and no impact to the patient.

Manufacturer Narrative

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

Event Description

Additional information was received.It was reported that the clamp became loose prior to putting the last screw in.After the case the clamp was checked and passed the checkout.

• Brand Name: SPINOUS PROCESS CLAMP
• 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: 9889286
• MDR Text Key: 185252654
• Report Number: 1723170-2020-01092
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131425
• 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: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9734716
• Device Catalogue Number: 9734716
• Device Lot Number: 170425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 80