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

Model Number 101-9812

Device Problems Mechanical Problem (1384); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model # 101-9814, lot # 800236, description: superion ids 14mm.

Event Description

It was reported that the procedure was aborted due to the first spacer not deploying properly and the second spacer not seating properly.The physician was not comfortable implanting the patient after the multiple attempts so the procedure was aborted.No patient harm was reported.

Manufacturer Narrative

Analysis of spacer lot number 800232 did not confirmed the reported complaint of failure to open, however, visual examination revealed significant damage.The right wing of the superior cam-lobe was significantly bent towards the median line.Although the cam-lobe was bent, the spacer functioned acceptably upon functional testing.The damage to the spacer indicates the failure was likely due to forced deployment against a rigid obstruction (spinous process).Analysis of spacer lot number 800236 revealed no defects as the implant was completely intact and functioned acceptably.

Event Description

It was reported that the procedure was aborted due to the first spacer not deploying properly and the second spacer not seating properly.The physician was not comfortable implanting the patient after the multiple attempts so the procedure was aborted.No patient harm was reported.

• 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: 9925369
• MDR Text Key: 186572703
• Report Number: 3006630150-2020-01643
• 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: 08/20/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 800232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 07/24/2020
• Supplement Dates FDA Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other