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

Model Number 101-9810

Device Problem Migration (4003)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patients original pain had returned.The superion interspinous spacer appeared to have migrated dorsal, however the patients original implant information was not available to confirm.The patient underwent a revision procedure and the physician tapped down the spacer back to the patients lamia.The patient was doing fine post-operatively.No further information can be obtained.

Event Description

It was reported that the patients original pain had returned.The superion interspinous spacer appeared to have migrated dorsal, however the patients original implant information was not available to confirm.The patient underwent a revision procedure and the physician tapped down the spacer back to the patients lamia.The patient was doing fine post-operatively.No further information can be obtained.

Manufacturer Narrative

Additional suspect medical device components involved in the event.Reference number: product family superion implant, upn 101-9810, model 101-9810, lot 700071, batch 700071.

• 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: 11219536
• MDR Text Key: 258601227
• Report Number: 3006630150-2021-00115
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 700068
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention