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

Catalog Number	9735129
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.Udi not available for this system at time of filing.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable as the lot number is unknown.A medtronic representative inspected the navigation system onsite and confirmed the spine clamp was broken.The clamp was replaced.The suspect part will not be returned to the manufacturer for evaluation as it was discarded at the site.
Event or Problem Description
A site representative reported that, while in a spinal fusion procedure the screw fixation on the spine clamp could not be properly fixed at the end of the surgery when the surgeon was removing the clamp.There was no reported delay to the procedure due to this issue and no impact on the patient outcome.

• Brand Name: INST KIT SPINE CLAMP
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7305843
• Report Number: 1723170-2018-00952
• Device Sequence Number: 957463
• Product Code: HAW
• UDI-Device Identifier: 00643169308879
• UDI-Public: 00643169308879
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K001153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2018

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: Physician
• Device Catalogue Number: 9735129
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1