MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC N/A; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 961-576

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Device was not evaluated by the manufacturer because the site has lost the device and could not return it for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a site representative regarding a navigation instrument.It was reported that prior to a case, the user tested the spine clam, and the screw was jammed.The site was able to move proceed by using a backup clamp.There was no patient present at the time of discovery.

• Brand Name: N/A
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8199397
• MDR Text Key: 131505886
• Report Number: 1723170-2018-06445
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 961-576
• Device Catalogue Number: 961-576
• Device Lot Number: 170214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: No
• 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