MAUDE Adverse Event Report: MEDTRONIC EXTRACTOR

Model Number 8657012

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 12/23/2020

Event Type  Injury  

Event Description

Implant verified to be in wrong position via o-arm image and removal instrument was non-functional as it would not close tightly to grip the cage.

• Brand Name: EXTRACTOR
• Type of Device: EXTRACTOR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 11308974
• MDR Text Key: 231982957
• Report Number: 11308974
• Device Sequence Number: 1
• Product Code: HWB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/05/2021

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
• Device Operator: Health Professional
• Device Model Number: 8657012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2021
• Distributor Facility Aware Date: 12/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR