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

Catalog Number	9734715
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.No parts returned for analysis.
Event or Problem Description
Information was received from a health care representative via manufacture representative about a spine clamp from a navigation system used during a sacroiliac and thoracolumbar procedure.It was reported that during the fusion, it was not possible for the clamp to engage to tighten it around the spinous process.A different clamp was selected to complete the procedure.There was no reported delay to the procedure due to this issue and no impact on the patient outcome.

• Brand Name: CLAMP, SPINOUS PROCESS TALL
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7401279
• Report Number: 1723170-2018-01478
• Device Sequence Number: 19180721
• Product Code: OLO
• UDI-Device Identifier: 00643169936300
• UDI-Public: 00643169936300
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 07/27/2018

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: 9734715
• Device Lot Number: 170425
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 07/27/2018
• 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: 91