MAUDE Adverse Event Report: VERTIFLEX INC. VERTIFLEX INSTRUMENT PLATFORM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number	140-9800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Respiratory Distress (2045); No Code Available (3191)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Additional suspect medical device components involved in the event: product family: superion instruments, upn: (b)(4), model: 102-9800, lot: 203995.
Event or Problem Description
It was reported the patient began having respiratory issues during the procedure to implant the device.It was assessed that the patient had a reaction to the anesthesia.The procedure was aborted and the patient will be scheduled at a future date.Patient is fine post-operatively.
Additional Manufacturer Narrative
H6 3191: no code available was used as there is no equivalent fda code for surgery.H2 if follow-up, what type - additional information.H6 evaluation method codes - analysis of production records 3331.H6 evaluation result codes - no device problem found 213.H6 evaluation conclusion codes - adverse event related to patient condition 50.Additional suspect medical device components involved in the event: product family: superion instruments, upn: (b)(4), model: 102-9800, lot: 203995.
Event or Problem Description
It was reported the patient began having respiratory issues during the procedure to implant the device.It was assessed that the patient had a reaction to the anesthesia.The procedure was aborted and the patient will be scheduled at a future date.Patient is fine post-operatively.
Event or Problem Description
It was reported the patient began having respiratory issues during the procedure to implant the device.It was assessed that the patient had a reaction to the anesthesia.The procedure was aborted and the patient will be scheduled at a future date.Patient is fine post-operatively.Additional information was received that the patient underwent the implant procedure.The patient is doing well post-operatively and is experiencing significant relief of neurogenic claudication symptoms.

• Brand Name: VERTIFLEX INSTRUMENT PLATFORM
• 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: 10900721
• Report Number: 3006630150-2020-05802
• Device Sequence Number: 16501298
• Product Code: NQO
• UDI-Device Identifier: 00884662000611
• UDI-Public: 00884662000611
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/13/2025
• Device Model Number: 140-9800
• Device Catalogue Number: 140-9800
• Device Lot Number: 203957
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 11/11/2020; 12/14/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/08/2020; 01/08/2021
• 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