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

Model Number 140-9800

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problem Pain (1994)

Event Date 08/10/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced pain in her back and legs approximately eight months following her superion indirect decompression spacer implant procedure.The physician assessed that the top of the cam lobes had migrated posteriorly way from the vertebral body.The patient underwent an explant procedure and is doing well post-operatively.

• Brand Name: VERTIFLEX INSTRUMENT PLATFORM
• Type of Device: 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16567444
• MDR Text Key: 311522645
• Report Number: 3006630150-2023-01343
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000611
• UDI-Public: 00884662000611
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Race: White