MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC 2.25 MM PEDICLE PROBE; INSTRUMENT, STEREOTAXIC

Model Number	9733457
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a cervical spine procedure.It was reported that when the cervical probe was used, it was found that the tip was deformed.The operation was performed with a different probe.There was no impact on the patient's outcome due to this issue.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received stating that even though the tip of the probe was bent, it was still able to verify on the system.
Additional Manufacturer Narrative
The probe was returned for analysis.The tip of the returned probe was not bent as was reported.There was no apparent physical damage.With markers attached and fully seated, the probe returned good geometry and divot error readings with normal tracking.No problem found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 2.25 MM PEDICLE PROBE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8836964
• Report Number: 1723170-2019-04258
• Device Sequence Number: 2070453
• Product Code: HAW
• UDI-Device Identifier: 00613994335968
• UDI-Public: 00613994335968
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2019

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: 9733457
• Device Catalogue Number: 9733457
• Device Lot Number: 160405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 07/30/2019; 07/30/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 08/22/2019; 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1