MAUDE Adverse Event Report: VERTIFLEX INC. SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number 101-9810

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

Patient Problems Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)

Event Date 11/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a follow up, the patient reported feeling new pain when he stands up.The pain varies with activity but it is present only when he is upright and active.The physician assessed that the new pain located in l4 was a result of a new acute compression fracture.It is not clear if the device caused the compression fracture in l4.The patient was administered a lumbar epidural injection.The device remains implanted and cannot be return for analysis.The patient is expected to fully recover.

Manufacturer Narrative

B1: adverse event/product problem.B5: describe event or problem.

Event Description

It was reported that during a follow up, the patient reported feeling new pain when he stands up.The pain varies with activity but it is present only when he is upright and active.The physician assessed that the new pain located in l4 was a result of an acute compression fracture.It is not clear if the device caused the compression fracture in l4.The patient was administered a lumbar epidural injection.The device remains implanted and cannot be return for analysis.The patient is expected to fully recover.Additional information was received that the compression fracture was related to the implanted device.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): VERTIFLEX INC.; 2714 loker ave. west; suite 100; carlsbad CA 92010
• MDR Report Key: 11058742
• MDR Text Key: 223365420
• Report Number: 3006630150-2020-06346
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000536
• UDI-Public: 00884662000536
• 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: 01/19/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 700077
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention