MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. STEFFIE TEMPLATE

Model Number 8572002

Patient Problem Foreign Body In Patient (2687)

Event Date 09/05/2023

Event Type  Injury  

Event Description

The steffie device broke off in the right l2 vertebral body.The piece was unable to be removed.The retained portion of the device was approx 1 inch long.

• Brand Name: STEFFIE TEMPLATE
• Type of Device: TEMPLATE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.
• MDR Report Key: 17735858
• MDR Text Key: 323373430
• Report Number: MW5145567
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• 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: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8572002
• Device Catalogue Number: FA11J006
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American