MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734683
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight not available 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 or Problem 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) was accessing the pedicure with the thoracic probe and it broke off in the patient¿s vertebral body.The hcp was hammering on the navlock when it broke.There was no reported impact to the patient.Additional information was received stating that the tip of the probe remained in the pedicle of the patient anatomy.The tip could not be removed because it would have caused more damage.

• Brand Name: NAVLOCK
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 12624206
• Report Number: 1723170-2021-02490
• Device Sequence Number: 13806837
• Product Code: OLO
• UDI-Device Identifier: 00763000076634
• UDI-Public: 00763000076634
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2021

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 Model Number: 9734683
• Device Catalogue Number: 9734683
• Device Lot Number: 200607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR