MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC UNIBODY 10MM BONE FIDUCIAL; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number FM-4010

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2021

Event Type  malfunction  

Event Description

A 3 medtronic bone fiducials unable to seat properly on the patient's skull.While placing the fiducials no pitch change was noted when drilling and was unable to engage fiducials to seat as securely as other fiducials in other cases.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC UNIBODY 10MM BONE FIDUCIAL
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION ; minneapolis MN 55432 5604
• MDR Report Key: 11613264
• MDR Text Key: 244179841
• Report Number: MW5100549
• Device Sequence Number: 1
• Product Code: HAW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/01/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2023
• Device Model Number: FM-4010
• Device Lot Number: 311426520A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 69