MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERTIFLEX INSTRUMENT PLATFORM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number 140-9800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Airway Obstruction (1699)

Event Date 03/17/2021

Event Type  Injury  

Event Description

It was reported that the patients airway became obstructed during a spacer implant procedure.As a result, the case was aborted.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: superion instruments.Upn: (b)(4).Model: 102-9800.Serial: n/a.Batch: 204019.

Event Description

It was reported that the patient's airway became obstructed during a spacer implant procedure.As a result, the case was aborted.Additional information was received that the opened kits were disposed by the facility and will not be returned.

• Brand Name: VERTIFLEX INSTRUMENT PLATFORM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; suite 100; valencia CA 91355
• MDR Report Key: 11671812
• MDR Text Key: 245585827
• Report Number: 3006630150-2021-01569
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• PMA/PMN Number: P140004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 140-9800
• Device Catalogue Number: 140-9800
• Device Lot Number: 204020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other