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

Model Number 100-0116

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 04/27/2017

Event Type  Injury  

Manufacturer Narrative

Device discarded by user facility.

Event Description

Subject was treated for relief of symptoms associated with lumbar spinal stenosis by implantation of superion ids device on (b)(6) 2017.While some indication of the possibility was suggested by intra-operative fluoroscopy, it was only upon review of additional radiographic imaging immediately after the procedure that it was determined conclusively that the implant had been mis-located, such that the implant was placed ventral to, rather than dorsal to, the lamina.The treating physician reports that a post-operative neurological examination was normal, and there was relief of symptoms.The mis-located implant was removed during a subsequent surgical decompression procedure, which occurred some hours later.No adverse sequelae were associated with the improper implant placement, excepting the need for subsequent decompression surgery (laminectomy) to remove the device.

• Brand Name: SUPERION INTERSPINOUS 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 ; 4423255914
• MDR Report Key: 6554170
• MDR Text Key: 74739618
• Report Number: 3005882106-2017-00003
• 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: 05/08/2017

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: Physician
• Device Expiration Date: 06/16/2021
• Device Model Number: 100-0116
• Device Catalogue Number: 100-9816
• Device Lot Number: 081572R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 05/09/2017
• 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): Required Intervention
• Patient Age: 72 YR