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

Model Number 101-9812

Device Problem Material Twisted/Bent (2981)

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

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model # 140-9800, serial # (b)(4), description: vertiflex instrument platform.

Event Description

It was reported that the procedure was aborted due to the physician having difficulty advancing the spacer through the cannula.Upon inspection of the spacer, it had been slightly bent.The patient was reportedly doing well following the procedure.

Manufacturer Narrative

Analysis of the 12mm spacer lot number 700078 was unable to confirm the reported complaint.The spacer was subjected to visual and functional examination.No defects could be confirmed as the spacer was completely intact and functioned acceptably.Analysis of the dilator of the cannula assembly lot number 193834 was unable to confirm the reported complaint.The device was subjected to visual and functional examination.No defects could be confirmed as the instrument was completely intact and functioned acceptably.

Event Description

It was reported that the procedure was aborted due to the physician having difficulty advancing the spacer through the cannula.Upon inspection of the spacer, it had been slightly bent.The patient was reportedly doing well following 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: 10370388
• MDR Text Key: 201865690
• Report Number: 3006630150-2020-03256
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• 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: 700078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR