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

Model Number	9734716
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturer representative went to the site and communicated with the staff about the design and intended function of the newest generation spinous clamp.The clamp in question was functioning as intended, though some modification may be necessary intraoperatively if a patient has a wide spinous process.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that during the select patient/acquire scans task of a sacroiliac and thoracolumbar procedure, the short spinous process clamp would not engage or disengage.The site opened another spine tray and were able to use that clamp.Patient information not available at the time of the call.There was a delay to the procedure of less than one hour.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPINOUS PROCESS CLAMP SHORT
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8077322
• Report Number: 1723170-2018-05682
• Device Sequence Number: 1887205
• Product Code: OLO
• UDI-Device Identifier: 00763000205317
• UDI-Public: 00763000205317
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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: Health Professional
• Device Model Number: 9734716
• Device Catalogue Number: 9734716
• Device Lot Number: 180118
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 86