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

Model Number 101-9812

Device Problem Difficult to Open or Close (2921)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model: 101-9810, serial/lot: (b)(4), description: superion ids 10mm.

Event Description

It was reported that the implant would not fully close when repositioning during a superion implant procedure because it appeared that there was tissue stuck inside the implant.After the physician tried to irrigate both the inserter and the implant, the implant would still not fully close.As a result, a new implant was used and placed at l4-5.However, the physician noticed the l4 spinous process was excessively mobile and concluded that it was fractured.The implant was removed and the procedure was aborted.It was also noted that there were osteophytes present that caused resistance and a sagittal wiggle under live fluoroscopy was used to identify the event.The physician did not use excessive force and did not gear shift during the procedure.The devices were disposed by the facility and will not be returned.The patient was doing well postoperatively and is in stable condition.

• 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
• Manufacturer (Section G): VERTIFLEX INC; 2714 loker ave. west; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 10658097
• MDR Text Key: 210688945
• Report Number: 3006630150-2020-04760
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000543
• UDI-Public: 00884662000543
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 800244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR