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

Model Number	101-9816
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model # 101-9814, lot# 700036, description: superion ids 14mm.
Event or Problem Description
A report was received that following the initial implant of a spacer the physician decided to try a larger spacer.The initial spacer was explanted and while trying to implant a larger spacer it was discovered that the implanting instruments were not holding firm.The physician removed everything from the patient and it was determined there was a spinous process fracture at l4.The physician decided to not implant the patient.There were no increased risk factors for a spinous process fracture.There was no unusual or contraindicated anatomy as well as there was no associated signs or symptoms of a spinous process fracture.The patient was reportedly doing well following the procedure.

• 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
• MDR Report Key: 9663256
• Report Number: 3006630150-2020-00345
• Device Sequence Number: 14142356
• Product Code: NQO
• UDI-Device Identifier: 00884662000567
• UDI-Public: 00884662000567
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 02/03/2020

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: Health Professional
• Device Expiration Date: 05/20/2024
• Device Model Number: 101-9816
• Device Catalogue Number: 101-9816
• Device Lot Number: 800130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 02/04/2020
• 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