MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, SPINOUS PROCESS SHORT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9734716
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device lot number, or serial number, unavailable at the time of filing.Device manufacture date is not available at time of filing.No parts have been returned to the manufacturer for analysis.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.The issue occurred intraoperatively during equipment setup and caused a five-minute delay to the surgery.It was reported that the surgeon had trouble engaging the screw with the short spine clamp.He struggled for about 5 minutes and then was able to get it.The surgery was completed with navigation and there was no impact on patient outcome.
Additional Manufacturer Narrative
Additional information: device lot number and manufacture date provided.

• Brand Name: CLAMP, SPINOUS PROCESS SHORT
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7660340
• Report Number: 1723170-2018-03132
• Device Sequence Number: 2629271
• Product Code: OLO
• UDI-Device Identifier: 00643169936294
• UDI-Public: 00643169936294
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

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
• Operator of Device: Physician
• Device Catalogue Number: 9734716
• Device Lot Number: 170905
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 63