MAUDE Adverse Event Report: VERTIFLEX, INC. SUPERION IDS; INTERSPINOUS SPACER

Model Number 8MM SUPERION IDS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Spinal Column Injury (2081)

Event Date 07/18/2018

Event Type  Injury  

Event Description

Physician reports that a patient he implanted with the superion device contacted him regarding onset of acute pain.Physician examined the patient and confirmed a spinous process fracture.Patient reports it occurred when line dancing.Physician advises he will treat for pain acutely and follow patient closely.Spinous process fractures are a recognized low-frequency risk associated with the subject device, and likelihood of occurrence is increased in the presence of certain known risk factors.It is not known whether any such risk factor(s) was (were) present in this case.

• Brand Name: SUPERION IDS
• Type of Device: INTERSPINOUS SPACER
• Manufacturer (Section D): VERTIFLEX, INC.; 2714 loker avenue west; suite 100; carlsbad CA 92010
• Manufacturer (Section G): VERTIFLEX, INC.; 2714 loker avenue west; suite 100; carlsbad CA 92010
• Manufacturer Contact: robert reitzler ; 2714 loker avenue west; suite 100; carlsbad, CA 92010 ; 4423255934
• MDR Report Key: 7782904
• MDR Text Key: 117129518
• Report Number: 3005882106-2018-00003
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000222
• UDI-Public: 00884662000222
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2018

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 Expiration Date: 03/20/2023
• Device Model Number: 8MM SUPERION IDS
• Device Catalogue Number: 100-9808
• Device Lot Number: 800013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other