MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 2.25 MM PEDICLE PROBE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9733457

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2016

Event Type  malfunction  

Manufacturer Narrative

Return requested.Replacement pedicle probe 2.25mm shipped to site (b)(4) 2016.No parts have been received by manufacturer for analysis.

Event Description

A medtronic representative reported that, while in a spinal cervical fusion procedure, the tip of their 2.25mm pedicle probe was bent.No further details regarding the damage, or how it occurred, were provided.The surgeon continued the procedure using a thoracic probe and completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.

• Brand Name: 2.25 MM PEDICLE PROBE
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6025027
• MDR Text Key: 57291860
• Report Number: 1723170-2016-02570
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994335968
• UDI-Public: 00613994335968
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9733457
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1