MAUDE Adverse Event Report: BOSTON SCIENTIFIC LIMITED DRIVER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number 1029800

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/02/2023

Event Type  Injury  

Event Description

2 vendor screw drivers broke during surgical procedure.Reference report: mw5118303.

• Brand Name: DRIVER
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC LIMITED
• MDR Report Key: 17107010
• MDR Text Key: 317065690
• Report Number: MW5118304
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1029800
• Device Lot Number: 4001B346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male