MAUDE Adverse Event Report: VERTIFLEX, INC. SUPERION IDS; INTERSPINOUS SPACER

Model Number 10MM SUPERION

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

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 08/09/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, this reporter received a telephone call from the wife of a patient who was treated at two (2) levels with the superion ids.She reported that 8-10 days after treatment, her husband (the patient) developed severe hip and leg pain.She stated that removal of the devices is scheduled in the near future, and asked if removal would resolve these symptoms.Subsequent communications with the implanting physician revealed that the patient originally presented with "classic" symptoms of moderate neurogenic claudication associated with lumbar spinal stenosis.Further, he noted that subsequent radiographic imaging establishes that the implants remain "perfectly placed".

• Brand Name: SUPERION IDS
• Type of Device: INTERSPINOUS SPACER
• Manufacturer (Section D): VERTIFLEX, INC.; 2714 loker avenue; suite 100; carlsbad CA 92010
• Manufacturer (Section G): VERTIFLEX, INC.; 2714 loker avenue west; suite 100; carlsbad CA 92010
• Manufacturer Contact: robert reitzler ; 2714 loker avenue west; suite 100; carlsbad, CA 92010 ; 4423255934
• MDR Report Key: 7783079
• MDR Text Key: 117130112
• Report Number: 3005882106-2018-00004
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000246
• UDI-Public: 00884662000246
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/14/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: 10MM SUPERION
• Device Catalogue Number: 100-9810
• Device Lot Number: 800010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other