MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, SPINOUS PROCESS TALL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9734715
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The tall spinous process clamp was returned to the manufacturer for analysis.Analysis found that the returned clamp was in very good condition with no apparent physical damage.The clamp was of the design that does not allow the attachment screw to be backed out completely and threads back into the base in order to close the clamp.Clamp functioned as designed.No failure found.Device manufacture date unavailable.
Event or Problem Description
Medtronic received information regarding a navigation system event having occurred outside of procedure.It was reported that the site had a broken tall, ¿new style¿ spine clamp.It was stated it had a stripped screw.No patient present.
Additional Manufacturer Narrative
Correction: manufacture date provided.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLAMP, SPINOUS PROCESS TALL
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7894734
• Report Number: 1723170-2018-04881
• Device Sequence Number: 19194915
• Product Code: OLO
• UDI-Device Identifier: 00643169936300
• UDI-Public: 00643169936300
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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: Health Professional
• Device Catalogue Number: 9734715
• Device Lot Number: 170425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1