MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PERCUTANEOUS REFERENCE CROSS PIN FRAME; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 9732353

Device Problem Material Integrity Problem (2978)

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

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

Device lot number unavailable.Udi not available for this instrument.No analysis was performed as the resolution was confirmed on the call.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used for a percutaneous fusion case.It was reported that intra-operatively, they were verifying instruments and the surgeon accidentally knocked the perc pin loose and the reference frame moved.The surgeon decided to abort navigation and move to fluoro.The procedure was completed and there was no reported impact to patient outcome.There was a reported delay to the procedure of less than one hour due to this issue.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the representative reported the packaging was discarded.And there wasn't anything wrong with the perc pin itself, just the placement of the perc pin.

• Brand Name: PERCUTANEOUS REFERENCE CROSS PIN FRAME
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8754065
• MDR Text Key: 149819823
• Report Number: 1723170-2019-03905
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9732353
• Device Catalogue Number: 9732353
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 77