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

Model Number 9733497

Device Problem Material Integrity Problem (2978)

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

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation system being used in a sacroiliac and thoracolumbar procedure.It was reported that the health care professional (hcp) opened and used a new product to complete the surgery.The broken part didn¿t fall in the patient, the instrument was remove from the bone and the hcp could see that the plastic part was broken but still attached.They removed the broken part from the rest of the instrument when the instrument was on the instrument table.It is unknown how the instrument broke.There was no reported impact on patient outcome.

• Brand Name: NAVIGATED NIM-SPINE PEDICLE ACCESS SYSTEM KIT
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12539817
• MDR Text Key: 273554620
• Report Number: 1723170-2021-02383
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169555495
• UDI-Public: 00643169555495
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2023
• Device Model Number: 9733497
• Device Catalogue Number: 9733497
• Device Lot Number: 210326K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1