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

Model Number	140-9800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an implant procedure, the patient was positioned on their stomach and incision was made.Then the dilator was inserted and the patient started to have difficulties with their oxygen and saturation levels.The procedure was aborted.The patient was flipped over and chest compressions were done due to the patient not breathing.Emergency medical services were called to attend to the patient and after the patient's blood pressure and oxygen saturation stabilized, the patient was taken to the hospital.The patient was in stable condition at the hospital.It was noted that the patient has pre-existing breathing issues.

• Brand Name: VERTIFLEX INSTRUMENT PLATFORM
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 12169602
• Report Number: 3006630150-2021-03774
• Device Sequence Number: 3821154
• Product Code: NQO
• UDI-Device Identifier: 00884662000611
• UDI-Public: 00884662000611
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P140004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2025
• Device Model Number: 140-9800
• Device Catalogue Number: 140-9800
• Device Lot Number: 204095
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other