MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CANNULA, 9732563, 100MM; INSTRUMENT, STEREOTAXIC

Model Number 9732563

Device Problems Material Integrity Problem (2978); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/10/2018

Event Type  Injury  

Manufacturer Narrative

Device lot number, or serial number, unavailable.Udi not available for this instrument at time of filing.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used during a sacroiliac and thoracolumbar procedure.It was reported that during a case on (b)(6) 2018, the cannula from the perc pin was left in the patient.This was discovered a few weeks after the procedure.The patient had additional surgery to remove the cannula.The size of the cannula was unknown.There was no reported surgical delay.

• Brand Name: CANNULA, 9732563, 100MM
• Type of Device: INSTRUMENT, STEREOTAXIC
• 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: 8091188
• MDR Text Key: 128010113
• Report Number: 1723170-2018-05766
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990214
• 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: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9732563
• Device Catalogue Number: 9732563
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: No
• 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: 54 YR
• Patient Weight: 120