MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVIGATED PEDICLE ACCESS KIT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 9733498

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used in a procedure.It was reported that the health care professional stating that the 2 pack needles broke during the procedure being used as usual.There was no delay to the procedure.No impact on patient outcome.No further information received.Additional information was received stating that the reported issue occurred during a spinal fusion procedure.There was only a few minute delay in the case, the time it took to pick up 2 other needles.The instrument did break inside of the patient anatomy and all broken pieces were removed.

• Brand Name: NAVIGATED PEDICLE ACCESS KIT
• 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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 11003393
• MDR Text Key: 221288568
• Report Number: 1723170-2020-03265
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2022
• Device Model Number: 9733498
• Device Catalogue Number: 9733498
• Device Lot Number: 200224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1