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

Model Number	9733497
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was reqested.The needle was discarded.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used during a spinal procedure.It was reported that the pak needle broke from the frame during use.The needle was removed without incident.Another needle was opened and used for the procedure.There was no patient harm and the procedure was not delayed.

• Brand Name: NAVIGATED NIM-SPINE PEDICLE ACCESS SYSTEM KIT
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11946142
• Report Number: 1723170-2021-01493
• Device Sequence Number: 13718039
• Product Code: MAX
• UDI-Device Identifier: 00643169555495
• UDI-Public: 00643169555495
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2021

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 Expiration Date: 12/08/2021
• Device Model Number: 9733497
• Device Catalogue Number: 9733497
• Device Lot Number: 191209A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1