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

Model Number 9734680

Device Problem Material Integrity Problem (2978)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2021

Event Type  Injury  

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 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
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12624262
• MDR Text Key: 276163600
• Report Number: 1723170-2021-02492
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K124004
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9734680
• Device Catalogue Number: 9734680
• Device Lot Number: 200821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR