MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) OPEN SPINE CLAMP, TITANIUM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9731780

Device Problems Unstable (1667); Material Deformation (2976); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was not made available from the site.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested for suspect open spine clamp.No parts have been received by manufacturer for analysis.No further issues have been reported.(b)(4).

Event Description

A medtronic representative reported that, while in a spine procedure, the site's open spine clamp was damaged.The surgeon was preparing to attach the spine clamp to the patient and it the spine clamp could not be tightened or untightened.The surgeon opted to continue the procedure using a different short spine clamp instead.No further details regarding the damage, or how it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.

• Brand Name: OPEN SPINE CLAMP, TITANIUM
• 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: 5496195
• MDR Text Key: 40207461
• Report Number: 1723170-2016-00341
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9731780
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2016
• 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