MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PROBE 9734434 LEFT LUMBAR TACTILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734434
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Device lot number, or serial number, unavailable.No parts were returned to the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a lumbar probe outside of a procedure.It was reported that the probe was damaged.There was no patient present when this issue was identified.It was not reported if the instrument was able to pass verification.

• Brand Name: PROBE 9734434 LEFT LUMBAR TACTILE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8667088
• Report Number: 1723170-2019-02915
• Device Sequence Number: 2268882
• Product Code: OLO
• UDI-Device Identifier: 00763000121273
• UDI-Public: 00763000121273
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2019

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: 9734434
• Device Catalogue Number: 9734434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1