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	Cerebrospinal Fluid Leakage (1772)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure to implant the superion indirect decompression spacer at the level of l4-l5, there was fluid return when repositioning dilator one resulting in a "wet tap".The physician then performed a blood patch, and had the patient lay flat for one hour while in recovery.The patient did well post-operatively and did not experience a headache following the procedure.

• 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
• Manufacturer (Section G): VERTIFLEX INC; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12763836
• Report Number: 3006630150-2021-06278
• Device Sequence Number: 3170795
• Product Code: NQO
• UDI-Device Identifier: 00884662000611
• UDI-Public: 00884662000611
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2021

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: 05/22/2025
• Device Model Number: 140-9800
• Device Catalogue Number: 140-9800
• Device Lot Number: 204026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female