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

Model Number	10MM SUPERION
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Therapeutic Response, Decreased (2271)
Date of Event	08/09/2018
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: INTERSPINOUS SPACER
• Manufacturer (Section D): VERTIFLEX, INC.; 2714 loker avenue; suite 100; carlsbad CA 92010
• MDR Report Key: 7783079
• Report Number: 3005882106-2018-00004
• Device Sequence Number: 11201932
• Product Code: NQO
• UDI-Device Identifier: 00884662000246
• UDI-Public: 00884662000246
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other