MAUDE Adverse Event Report: BOSTON SCIENTIFIC LIMITED VERTIFLEX SUPERION IDS - 10MM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number 101-9810

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/21/2022

Event Type  malfunction  

Event Description

Patient was under mac anesthesia for a vertiflex procedure at l3-l4.Upon insertion, the top of the device broke off.The physician successfully removed all pieces with an x-ray to verify.The company rep, (b)(4), retrieved all pieces off back table and placed into sterile container to send to company.Fda safety report id# (b)(4).

• Brand Name: VERTIFLEX SUPERION IDS - 10MM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC LIMITED
• MDR Report Key: 13862304
• MDR Text Key: 287820899
• Report Number: MW5108422
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/21/2022

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: 101-9810
• Device Lot Number: 700068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White