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 Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2020

Event Type  malfunction  

Event Description

It was reported that during the implant procedure the top of the spacer implant came off.The physician attempted to retrieve the spacer and was unable to successfully.To avoid possible additional complication, he decided to leave the spacer in place.The patient was doing well post operatively.

Event Description

It was reported that during the implant procedure the top of the spacer implant came off.The physician attempted to retrieve the spacer and was unable to successfully.To avoid possible additional complication, he decided to leave the spacer in place.The patient was doing well post operatively.

Manufacturer Narrative

Device technical analysis: visual inspection of the returned spindle and an actuator from a 101-series 12 mm implant of lot number 800330 revealed components of the implant clearly suggested that the spindle cap was completely sheared off from the implant body.Since only retrieved components were returned, no functional testing could be performed.The damage to the implant indicates failure likely due to a combination of deployment against resistance, e.G.Bone, and physician failing to correctly attach the inserter to the spacer.Investigation conclusion: the investigation concluded that the reported event of the top of the spacer implant coming off during implant procedure was confirmed through device analysis therefore the most probable root cause is traced to unintended use error caused or contributed to event.

Event Description

It was reported that during the implant procedure the top of the spacer implant came off.The physician attempted to retrieve the spacer and was unable to successfully.To avoid possible additional complication, he decided to leave the spacer in place.The patient was 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: 10408544
• MDR Text Key: 202959414
• Report Number: 3006630150-2020-03428
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 800330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention