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

Model Number 101-9812

Device Problem Material Integrity Problem (2978)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: superion implant, upn: (b)(4), model: 101-9810, serial: n/a, batch: 700060.

Event Description

It was reported that during the vertiflex implant procedure for the lumbar 3 and 4 the procedure had to be aborted.During the attempt to implant of a 12 inch spacer it broke, another attempt to implant was made with a 10 inch spacer which broke as well.It was then decided to abort the procedure.It was noted that the spinous processes was tight and there was resistant space.It is believed that the spinous processes were very thick and that poor patient positioning also contributed to the difficulty of the implant.It was noted that appropriate force was used during the procedure.

Manufacturer Narrative

101-9812; 700084: it was reported that the 12mm implant broke under much stress.The spindle cap was completely sheared off from the implant body.The damage to implant indicates failure was due to a combination of deployment against resistance, such as bone, and physician failing to correctly attach the inserter to the spacer.The probable cause is unintended use error caused or contributed to event.101-9810; 700060: it was report that the 10 inch implant broke.The spindle cap was completely sheared off from the implant body.The damage to implant indicates failure was likely due to a combination of deployment against resistance, such as bone, and physician failing to correctly attach the inserter to the spacer.The probable cause is unintended use error caused or contributed to event.

Event Description

It was reported that during the vertiflex implant procedure for the lumbar 3 and 4 the procedure had to be aborted.During the attempt to implant of a 12 inch spacer it broke, another attempt to implant was made with a 10 inch spacer which broke as well.It was then decided to abort the procedure.It was noted that the spinous processes was tight and there was resistant space.It is believed that the spinous processes were very thick and that poor patient positioning also contributed to the difficulty of the implant.It was noted that appropriate force was used during the procedure.

Event Description

It was reported that during the vertiflex implant procedure for the lumbar 3 and 4 the procedure had to be aborted.During the attempt to implant of a 12 inch spacer it broke, another attempt to implant was made with a 10 inch spacer which broke as well.It was then decided to abort the procedure.It was noted that the spinous processes was tight and there was resistant space.It is believed that the spinous processes were very thick and that poor patient positioning also contributed to the difficulty of the implant.It was noted that appropriate force was used during 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: 10738057
• MDR Text Key: 213162589
• Report Number: 3006630150-2020-05174
• 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,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 700084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 10/28/2020; 10/29/2020
• Supplement Dates FDA Received: 10/28/2020; 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other