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

Catalog Number	9731780
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested for suspect spinous process tall clamp.No parts have been received by manufacturer for analysis.On 11/02/2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.On 11/28/2016 a medtronic representative, following-up at the site, reported the issue was due to a user error.There was no damage to the spinous process tall clamp and the site declined to replace it.The site used the same spinous process tall clamp in a subsequent procedure the following day, without issue.
Event or Problem Description
A medtronic representative reported that, while in a spine procedure, the surgeon noted that the screw that held their spinous process tall clamp and the spine reference frame together was loose.This did not cause any issues, and no delay in therapy.The surgeon opted to continue and completed the procedure with the use of the navigation system.There was no impact on patient outcome.
Additional Manufacturer Narrative
The site has chosen not to replace/return the part, since there was no actual malfunction.

• Brand Name: OPEN SPINE CLAMP, TITANIUM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6129940
• Report Number: 1723170-2016-02993
• Device Sequence Number: 13578297
• Product Code: HAW
• UDI-Device Identifier: 00643169540453
• UDI-Public: 00643169540453
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K990214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2017

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: 9731780
• Device Lot Number: 141120
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2016
• Supplement Report FDA Received Date: 03/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 86