MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAV LUMBAR PROBE TIP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9734679

Device Problem Material Integrity Problem (2978)

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

Weight: patient weight not available.Device evaluated by mfr: no parts have been returned to medtronic for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding navigation devices being used for a sacroiliac and thoracolumbar procedure.It was reported that the thoracic probe was noticeably bent.This was observed during the clinical case.The thoracic probe passed verification; it bent after verification.It was also reported that the tip of the straight lumbar probe broke off during the procedure and was found during the procedure.The lumbar probe tip broke off while inside patient anatomy, and the tip ended up in the pedicle.The lumbar probe tip was located with fluoro, and it was retrieved by careful burring down by the surgeon and then it was suctioned out.The broken piece caused a delay of 45 minutes to the case.The surgeon proceeded with the case by using a backup tray.There was no reported impact on patient outcome; the patient did not experience any symptoms due to this event.

• Brand Name: NAV LUMBAR PROBE TIP
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8571111
• MDR Text Key: 143752386
• Report Number: 1723170-2019-02104
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9734679
• Device Catalogue Number: 9734679
• Device Lot Number: 180818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2018
• 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): Required Intervention
• Patient Age: 46 YR