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

Catalog Number	9734716
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier not available from the site.Patient weight not available from the site.No parts have been received by the manufacturer for evaluation.
Event or Problem Description
A medtronic representative reported that, while in a spinal fusion, the spine clamp was found to have a washer missing following its use in the procedure.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.No additional information was provided.
Additional Manufacturer Narrative
Device code was corrected.If information is provided in the future, a supplemental report will be issued.

• 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: 7329898
• Report Number: 1723170-2018-00921
• Device Sequence Number: 10789232
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

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: Physician
• Device Catalogue Number: 9734716
• Device Lot Number: 160729
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/11/2018
• Supplement Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR