MAUDE Adverse Event Report: VERTIFLEX, INC. SUPERION INDIRECT DECOMPRESSION SYSTEM; INTERSPINOUS SPACER

Model Number 102-9108

Device Problems Difficult or Delayed Positioning (1157); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2018

Event Type  malfunction  

Manufacturer Narrative

Upon receipt of the device, visual examination confirmed that the distal tip of the manual driver had fractured.The reporter noted that the patient was ankylosed and scoliotic, both of which conditions are contraindicated and would have caused significant resistance to proper alignment and deployment of the implant.Application of excessive force in deployment may have been proximate cause for the driver tip fracture, but the reporter also stated that due to difficulty in deployment of the implant, the treating physician "finished deployment with [a] mallet".This technique is not recommended, and may also have contributed to the driver tip fracture.

Event Description

During attempts to place a superion ids implant at l4/l5, significant resistance to deployment was encountered.To overcome this resistance, excessive torque was applied by the treating physician in an attempt to deploy the implant, with the result that one (1) 10mm implant was broken.This implant was successfully removed without issue, and a second implantation attempted.While this implant was successfully placed, albeit after the physician used a mallet to finish deployment, during deployment the tip of the manual driver instrument fractured.A portion of the fractured tip remained firmly engaged within the distal end of the implant body, and was allowed by the physician to remain in situ.It is notable that the patient presented with both ankylosis and significant scoliosis, which are both contraindicated conditions, and would have been the proximate cause(s) of the resistance to deployment encountered.Several unsuccessful attempts have been made to contact the treating physician to discuss the ramifications of the driver fragment left in situ.We will continue to attempt to follow up with the clinician.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• 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: 7991718
• MDR Text Key: 126116930
• Report Number: 3005882106-2018-00007
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000123
• UDI-Public: 00884662000123
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2023
• Device Model Number: 102-9108
• Device Catalogue Number: 140-9800
• Device Lot Number: 183189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Date Manufacturer Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other