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

Model Number 101-9812

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

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

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model # 101-9812.Lot # unknown.Description: superion ids 12mm.

Event Description

It was reported that two spacers were explanted from the patient due to spinous process fractures at l3/4 and l4/5.The patient reported pain at the operative site since the fractures.The patient was reportedly doing well following the procedure.

Manufacturer Narrative

Additional suspect medical device components involved in the event: model # 101-9812, lot # 800225, description: superion ids 12mm.Analysis of 12mm implant lot number 700049 confirmed there was no defects as the implant was completely intact and functioned acceptably.Analysis of 12mm implant lot number 800225 confirmed there was no defects as the implant was completely intact and functioned acceptably.

Event Description

It was reported that two spacers were explanted from the patient due to spinous process fractures at l3/4 and l4/5.The patient reported pain at the operative site since the fractures.The patient was reportedly doing well following the procedure.

• 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: 10029689
• MDR Text Key: 190033541
• Report Number: 3006630150-2020-01981
• 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: 09/28/2020

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
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 700049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 05/06/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention