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

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

Patient Problems Erosion (1750); Bone Fracture(s) (1870); Pain (1994)

Event Date 01/29/2020

Event Type  Injury  

Event Description

A report was received that three days following the implant the patient reported worsening pain in a pre-existing pain area.Mri revealed a small left l3 l4 lateral disc extrusion with mild foraminal narrowing.Patient tried conservative measures for 1 month, however, those were not successful.The patient then underwent a left l3 l4 microdiscectomy which relieved radiculopathy, but not axial back pain.With physical therapy and increased medication for two months pain still persisted.New mri ordered showed a small l3 inferior endplate abnormality which was not present in previous mris.Abnormalities found on postop mri may be an endplate fracture at the level of the iss device.Postoperative ct was inconclusive for endplate fracture.Possible causes of this patient's disc herniation post implantation may include non-compliance to tlso brace and obesity.

• Brand Name: SUPERION INTERSPINOUS SPACER
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): VERTIFLEX INC.; 2714 loker ave. west; suite 100; carlsbad CA
• Manufacturer (Section G): VERTIFLEX INC.; 2714 loker ave. west; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 9766453
• MDR Text Key: 181921393
• Report Number: 3006630150-2020-00843
• Device Sequence Number: 1
• Product Code: NQO
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2020

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR