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

Model Number 101-9814

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/16/2020

Event Type  Injury  

Event Description

It was reported that during an implant procedure the patients l4 spinous process was fractured.The fracture occurred during a two level implant procedure at l3/l4 and l4/l5 when the second spacer at l3/l4 was placed.The spacer at l3/l4 remained implanted while the spacer at l4/l5 was removed.The device was discarded by the facility and will not be returned for analysis.The patients status is unknown.

Event Description

It was reported that during an implant procedure the patients l4 spinous process was fractured.The fracture occurred during a two level implant procedure at l3/l4 and l4/l5 when the second spacer at l3/l4 was placed.The spacer at l3/l4 remained implanted while the spacer at l4/l5 was removed.The device was discarded by the facility and will not be returned for analysis.The patients status is unknown.Additional information was received that the patient 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 92010
• MDR Report Key: 11137787
• MDR Text Key: 225723237
• Report Number: 3006630150-2020-06619
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000550
• UDI-Public: 00884662000550
• 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: 02/05/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101-9814
• Device Catalogue Number: 101-9814
• Device Lot Number: 800275
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention