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

Model Number 14MM

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Bone Fracture(s) (1870); Tissue Damage (2104)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

Initial report provided by the physician, as conveyed by manufacturer's sales representative, suggested that in post-operative films acquired approximately 100 days following the initial implantation of two superion devices there appeared to be evidence of dislodgement of the superior (l3/l4 device).The product remained in situ, and at the time there was no indication that this was a reportable event.In a telephone conversation between this reporter and the treating physician on (b)(6), the x-rays images were reviewed and it was agreed that the "dislodgement" originally observed by the physician was actually evidence of a fracture of the l4 spinous process.As a result of the determination that an injury (fracture) had occurred, the report was now considered a reportable event.Spinous process fracture is a recognized, low-level risk associated with the superion product, and its occurrence and certain risk factors associated with its likelihood are described in the labeling.

Event Description

Manufacturer's case coverage specialist forwarded x-ray images suggesting "dislodgement of l3-4 superion." device remains in situ.

• 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: 6863372
• MDR Text Key: 86082337
• Report Number: 3005882106-2017-00005
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000284
• UDI-Public: 00884662000284
• 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: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 14MM
• Device Catalogue Number: 100-9814
• Device Lot Number: 112166R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2016
• 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