MAUDE Adverse Event Report: VERTIFLEX, INCORPORATED SUPERION INTERSPINOUS DECOMPRESSION SYSTEM; INTERSPINOUS SPACER

Model Number 100-9135

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 11/03/2017

Event Type  Injury  

Event Description

Patient was treated to relieve neurogenic claudication symptoms of lumbar spinal stenosis on (b)(6), by implantation of subject device.During the procedure, when advancing the access cannula, the first of two dilators "backed up" (dorsally) out of position.When the physician tapped the first dilator back into position, it advanced farther than desired.The physician immediately removed all instrumentation.Patient was under light sedation, and was able to speak to confirm his condition was "ok," and was able to feel and move lower extremities.The physician saw a small amount of fluid that he presumed might have been csf.The fluid stopped spontaneously, and the physician proceeded to complete the procedure.Patient was checked in recovery and reported a slight headache when walking.Patient was kept overnight for observation, and discharged the following morning.Per (b)(6) follow-up, patient reported no headache or other adverse sequelae, with >80% relief of lumbar stenosis symptoms.Per (b)(6) follow-up, patient reported no headache or other adverse sequelae, with >90% relief of lumbar stenosis symptoms.As of this date, patient continues to enjow relief from symptoms with no adverse sequelae.

• Brand Name: SUPERION INTERSPINOUS DECOMPRESSION SYSTEM
• Type of Device: INTERSPINOUS SPACER
• Manufacturer (Section D): VERTIFLEX, INCORPORATED; 2714 loker avenue west; suite 100; carlsbad CA 92010
• Manufacturer (Section G): VERTIFLEX, INCORPORATED; 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: 7143364
• MDR Text Key: 95723004
• Report Number: 3005882106-2017-00006
• Device Sequence Number: 1
• Product Code: NQO
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 100-9135
• Device Catalogue Number: 100-9135
• Device Lot Number: 162698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other