MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION BOSTON SCIENTIFIC SUPERION VERTIFLEX SCREWDRIVER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Patient Problem Foreign Body In Patient (2687)

Event Date 04/19/2023

Event Type  Injury  

Event Description

Boston science screwdriver broke into the superion 10mm indirect decompression system implant inside the patient.All parts of broken screwdriver removed from patient and xray taken to confirm - xray negative.Further attempts aborted and patient's symptoms unrelieved after surgery.

• Brand Name: BOSTON SCIENTIFIC SUPERION VERTIFLEX SCREWDRIVER
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• MDR Report Key: 17550778
• MDR Text Key: 321272626
• Report Number: MW5144561
• Device Sequence Number: 1
• Product Code: NQO
• 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: 08/09/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American