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

Catalog Number	9731780
Medical Device Problem Codes	Material Deformation (2976); Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return requested for suspect spine clamp.No parts have been received by manufacturer for analysis.On 01/23/2017, a medtronic representative, following-up at the site, reported the surgeon was trying to tighten the clamp on the spinous process and it just would not tighten down.A second clamp was used to continue the procedure.
Event or Problem Description
A medtronic representative received a report from that while in a spine procedure, the site's spine clamp was damaged and no longer works properly.No further details regarding the damage, or how it occurred, were provided.A second clamp was used to continue the procedure to completion.Delay in therapy was less than one hour.There was no impact on patient outcome reported.
Additional Manufacturer Narrative
Device manufacturing date is now provided.
Additional Manufacturer Narrative
Additional information: patient age, weight and gender provided.There was a reported delay to the procedure of less than 1 hour due to this issue.

• 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: 6283529
• Report Number: 1723170-2017-00248
• Device Sequence Number: 1709533
• Product Code: HAW
• UDI-Device Identifier: 00643169308879
• UDI-Public: 00643169308879
• 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,Followup
• Report Date (Section B): 04/17/2017

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: 120605
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/27/2017
• Supplement Report FDA Received Date: 02/24/2017; 04/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 120