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

Catalog Number	9734715K
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation as the site declined to replace the instrument.
Event or Problem Description
Medtronic received information regarding a navigation system being used during a mast/perc spinal fusion.It was reported that intra-operatively, while setting up equipment.The tall hex screw spinous process clamp would close when the clamp was held in the air, but not when positioned around a spinous process.Surgery was completed using the navigation system and a different set of spinous process clamps.Surgical time was extended by less than one hour and there was no reported patient impact.

• Brand Name: SPINOUS PROCESS CLAMP TALL
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7571775
• Report Number: 1723170-2018-02532
• Device Sequence Number: 1979828
• Product Code: OLO
• UDI-Device Identifier: 00643169936317
• UDI-Public: 00643169936317
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2018

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: 9734715K
• Device Lot Number: 170905
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 120