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

Catalog Number 9733457

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2015

Event Type  malfunction  

Manufacturer Narrative

The site declined to provide patient information, per (b)(4) privacy laws.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.No parts have been received by manufacturer for analysis.No further issues have been reported.Part not received by manufacturer.

Event Description

A medtronic representative reported that, while in a spine procedure, the surgeon used the 2.25 millimeter pedical probe on sacral region.While using the probe, the tip bent.The surgeon opted to continue and completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.

Manufacturer Narrative

Lot number and device manufacture date provided.

• 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 5377536
• MDR Text Key: 36347023
• Report Number: 1723170-2016-00069
• Device Sequence Number: 1
• Product Code: HAW
• 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,Followup
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9733457
• Device Lot Number: 080722
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2008
• 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