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

Model Number BI-700-00027-120

Device Problems Imprecision (1307); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

Patient identifier not available from the site.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding an imaging device being used for a spinal fusion procedure.It was reported that the system had imprecision by 1mm with the left side of the imaging system.The manufacturing representative (rep) re calibrated the system and confirmed they were immediately imprecise.The site took into account the amount of imprecision and proceeded.There was no reported impact on patient outcome.There was a reported delay to the procedure of less than 1 hour due to this issue.No further information was provided.

Manufacturer Narrative

Patient identifier not available from the site.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation instrument being used for a spinal fusion procedure.It was reported that the short clamp does not close.The redesign that was made it difficult to close the clamp.The threads had been removed at the top and if it is opened too wide, the threading in the screw is too far away from the threading in the screw hole.Thus, the clamp would not work on too thick of spinous process.There was no reported impact on patient outcome.There was no reported delay to the procedure due to this issue.No further information was provided.

Manufacturer Narrative

Added in the event summary, how the issue was resolved.

Event Description

Medtronic received information regarding a navigation instrument being used intra-operatively for a spinal fusion procedure.It was reported that the short clamp does not close.The redesign made it difficult to close the clamp.The threads had been removed at the top and, if it is opened too wide, the threading in the screw is too far away from the threading in the screw hole.Thus, the clamp would not work on too thick of spinous process.There was no reported impact on patient outcome.It was further reported that the issue was resolved by informing the customer about the deficiency in the product and how to work around it.There was no reported delay to the procedure due to this issue.No further information was provided.

Manufacturer Narrative

Fda codes were updated to reflect current coding guidelines.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLAMP, SPINOUS PROCESS SHORT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7480553
• MDR Text Key: 107146358
• Report Number: 1723170-2018-01846
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9734716
• Device Lot Number: 170207
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 70