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

Catalog Number	9734402
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Manufacturing date was unavailable at the time of filing.No parts have been returned to the manufacturer for analysis.
Event or Problem Description
Medtronic received information that, while outside a procedure, the straight lumbar probe was identified as being bent.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
Additional information: manufacture date provided.Correction: unique device identification (udi) updated to proper value.

• 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: 7877818
• Report Number: 1723170-2018-04676
• Device Sequence Number: 2217525
• Product Code: OLO
• UDI-Device Identifier: 00763000053819
• UDI-Public: 00763000053819
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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: Health Professional
• Device Catalogue Number: 9734402
• Device Lot Number: 100213
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1