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

Model Number 101-9812

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was experiencing back and leg pain when standing.It was assess that the implanted spacer was not sitting flush to the spinolaminar junction.Patient then underwent a revision procedure to replace the spacer and is doing well post-operatively.

Manufacturer Narrative

H6 patient code 3191: no code available was used because there is not an equivalent fda code for surgical intervention.Visual examination of the returned 101-series 12mm implant lot number 800235 revealed that the right wing of the superior cam-lobe was minutely bent towards the median line.The implant functioned acceptably upon functional testing and the damage to implant indicates failure was likely due to forced deployment against a rigid obstruction such as the spinous process.The complaint of malposition of the device was confirmed through device analysis.The probable cause was traced to unintended use error caused or contributed to the event.

Event Description

It was reported that the patient was experiencing back and leg pain when standing.It was assessed that the implanted spacer was not sitting flush to the spinolaminar junction.Patient then underwent a revision procedure to replace the spacer and is doing well post-operatively.

• 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
• MDR Report Key: 10791354
• MDR Text Key: 214750981
• Report Number: 3006630150-2020-05358
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000543
• UDI-Public: 00884662000543
• 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: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• 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: 800235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention