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

Model Number	101-9816
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was explanted due to the spacer being displaced.The spacer was kept by the medical facility.
Event or Problem Description
It was reported that the patient was explanted due to the spacer being displaced.The spacer was kept by the medical facility.Additional information was received that the patient reported that something was unusual at a post op visit.The patient reported feeling a popping sensation with increased pain in his leg while stretching.During the procedure the original spacer was removed and a larger spacer was implanted.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): VERTIFLEX INC.; 2714 loker ave. west; suite 100; carlsbad CA 92010
• MDR Report Key: 9884827
• Report Number: 3006630150-2020-01462
• Device Sequence Number: 19518189
• Product Code: NQO
• UDI-Device Identifier: 00884662000567
• UDI-Public: 00884662000567
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P140004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/27/2024
• Device Model Number: 101-9816
• Device Catalogue Number: 101-9816
• Device Lot Number: 800223
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention