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 Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing severe back pain following a superion indirect decompression spacer implant procedure.The patient was admitted to the emergency room where an x-ray was taken which revealed that the patient had a process fracture at the level of the spacer implant.The device remains implanted.No further information has been obtained despite good faith efforts.

• 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): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14518743
• Report Number: 3006630150-2022-02525
• Device Sequence Number: 14824586
• Product Code: NQO
• UDI-Device Identifier: 00884662000611
• UDI-Public: 00884662000611
• Combination Product (Y/N): N
• 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): 05/26/2022

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: Lay User/Patient
• Device Expiration Date: 02/28/2026
• Device Model Number: 140-9800
• Device Catalogue Number: 140-9800
• Device Lot Number: 26887527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown