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

Model Number 100-0108

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

Case report provided by manufacturer's clinical specialist, who was observing the procedure, suggests spinous processes were grossly misaligned.This is potentially an indication of a degree of scoliosis (>10 degrees) which, if it were the case, would be contraindicated.Further, initial attempts by the user to deploy the implant failed because of obstruction by bony anatomy (likely l4 spinous process).Under such circumstances, users are instructed to close (undeploy) the implant and reposition it such that it is clear of the bony obstruction prior to re-deploying it.The user instead attempted to drive the implant ventrally with a mallet in an attempt to force deployment.This, too, failed, and the user continued to try to force deployment despite the bony obstruction, which resulted in failure of an implant component.This is the first report of this type of event ever received.Device remains in situ.

Event Description

Pt.Was undergoing an l4/l5 implantation for relief of symptoms secondary to lumbar spinal stenosis.Severe abnormal alignment/scoliosis of l4 and l5 spinous processes was observed, which inhibited proper deployment (opening) of the implant.The physician felt he could partially deploy the implant, and then drive it ventrally against the lamina, which would fully deploy the device.He proceed to impact the partially deployed implant ventrally against the lamina with an orthopedic mallet in an attempt to complete deployment of the implant and seat it more fully.This, despite clinical specialist's caution against doing so.The attempt was unsuccessful, as the implant was prevented from deploying fully by obstruction from the misaligned l4 spinous process.Despite the l4 spinous process obstructing the implant, the physician continued to attempt to force implant deployment, at which time the right superior portion of the cam lobe broke off the implant.When asked by the clinical specialist if he'd like to remove the broken implant and try a new device, the physician chose to leave the broken implant in the patient, as he believed it restored the segmental height where it was.Device remains in situ.

• Brand Name: SUPERION INTERSPINOUS SPACER
• Type of Device: INTERSPINOUS SPACER
• Manufacturer (Section D): VERTIFLEX, INC.; 1351 calle avanzado; san clemente CA 92673
• Manufacturer (Section G): VERTIFLEX, INC.; 1351 calle avanzado; san clemente CA 92673
• Manufacturer Contact: robert reitzler ; 1351 calle avanzado; san clemente, CA 92673 ; 9499401434
• MDR Report Key: 6146090
• MDR Text Key: 61733008
• Report Number: 3005882106-2016-00003
• 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: Other
• Type of Report: Initial
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/01/2020
• Device Model Number: 100-0108
• Device Catalogue Number: 100-9808
• Device Lot Number: 081274R1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2015
• 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: 68 YR
• Patient Weight: 77