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

Catalog Number	9734716
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.Device lot number unavailable.Device manufacturing date is dependent on lot number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that the spine clamp was damaged.The retention screw was stripped.There was no patient impact and a less than 5 minute delay while a new tray was opened to get another clamp.
Additional Manufacturer Narrative
Correction: device lot number updated to proper value.Device manufacturing date updated to proper value.

• 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: 7643827
• Report Number: 1723170-2018-03029
• Device Sequence Number: 16598909
• Product Code: OLO
• UDI-Device Identifier: 00643169936294
• UDI-Public: 00643169936294
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: 170207
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1