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

Model Number 101-9812

Device Problems Material Twisted/Bent (2981); Migration (4003)

Patient Problem No Code Available (3191)

Event Date 08/06/2020

Event Type  Injury  

Event Description

It was reported that the patient was experiencing increased pain.It was assessed that the device was slightly off center and believed to be placed too medial during the implant procedure.It is believed that when the patient stood the device was loaded and bent the lobe.The patient underwent a device replacement and was doing well post-operatively.

Manufacturer Narrative

An analysis was performed on the returned device which revealed that the device suffered significant damage, i.E., the left wing of the superior cam-lobe was significantly bent away from the median line and the right wing was broken.However, the implant functioned acceptably upon functional testing.The damage to implant indicates failure likely due to implant malposition or incorrect orientation, which resulted in the damage-breaking of the implant.

Event Description

It was reported that the patient was experiencing increased pain.It was assessed that the device was slightly off center and believed to be placed too medial during the implant procedure.It is believed that when the patient stood the device was loaded and bent the lobe.The patient underwent a device replacement and 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 92010
• MDR Report Key: 10468945
• MDR Text Key: 204861366
• Report Number: 3006630150-2020-03766
• 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: 09/11/2020

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: 700076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR