MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) LUMBAR PROBE TIP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9734402
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.No further analysis can take place at this time.Part not received by manufacturer.
Event or Problem Description
A medtronic representative reported that the tip of the lumbar probe was found to be twisted during a spinal fusion procedure.The instrument was still reportedly usable and the procedure was completed successfully with it.This issue did not cause a delay and the patient was not impacted.

• Brand Name: LUMBAR PROBE TIP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6016770
• Report Number: 1723170-2016-02545
• Device Sequence Number: 39851
• Product Code: OLO
• UDI-Device Identifier: 00613994724021
• UDI-Public: 00613994724021
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/11/2016

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: 9734402
• Device Lot Number: 120516
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2016
• Initial Report FDA Received Date: 10/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 97