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

Model Number 101-9812

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: superion implant, upn: (b)(4), model: 101-9812, lot: unknown.(b)(4).

Event Description

It was reported that the patient underwent an explant procedure to remove both of the superion implanted devices as a result of a spinous process fracture.Both of the implanted devices had dislodged from the fractured spinous process, causing increased pain to the patient.The explanted devices were discarded by the facility and will not be returned for analysis.The patient is doing well post-operatively.

Event Description

It was reported that the patient underwent an explant procedure to remove both of the superion implanted devices as a result of a spinous process fracture.Both of the implanted devices had dislodged from the fractured spinous process, causing increased pain to the patient.The explanted devices were discarded by the facility and will not be returned for analysis.The patient is doing well post-operatively.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: superion implant.Upn: (b)(4); model: 101-9812; lot: 800308.

• 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: 11052410
• MDR Text Key: 223056737
• Report Number: 3006630150-2020-06316
• 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: 02/04/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 800312
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/12/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR