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 Fever (1858); Bone Fracture(s) (1870); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Skin Irritation (2076); Burning Sensation (2146)

Event Date 01/25/2020

Event Type  Injury  

Event Description

A report was received that a patient developed a herpes simplex infection at the well healing implant site 10 days after the spacer was implanted.The patient developed clusters of small vesicles in the lumber region.The patient reported burning symptoms and a return of her inability to walk.The patient was initially treated with antibiotic but the infection did not resolve.The patient then developed a fever 14 days after implantation and was hospitalized.A spinous process fracture was also noted.The patient was then treated with a different iv antibiotic and the issue resolved.

Event Description

A report was received that a patient developed a herpes simplex infection at the well healing implant site 10 days after the spacer was implanted.The patient developed clusters of small vesicles in the lumbar region.The patient reported burning symptoms and a return of her inability to walk.The patient was initially treated with antibiotic but the infection did not resolve.The patient then developed a fever 14 days after implantation and was hospitalized.A spinous process fracture was also noted.The patient was then treated with a different iv antibiotic and the issue resolved.

• 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 92010
• MDR Report Key: 9741679
• MDR Text Key: 188807790
• Report Number: 3006630150-2020-00724
• Device Sequence Number: 1
• Product Code: NQO
• 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: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• 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
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention