MAUDE Adverse Event Report: NEXXT SPINE LLC 66MM 3 LEVEL PLATE, 18MM VST SCREW, 16MM VST SCREW, 18MM VSD SCREW; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Model Number 31-3-66, 31-8-4018, 31-8-4016

Device Problems Break (1069); Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979)

Patient Problems Failure of Implant (1924); Distress (2329); Discomfort (2330)

Event Date 01/01/2020

Event Type  Injury  

Event Description

In (b)(6) 2018, i had a spinal fusion surgery performed in my cervical spine.The hardware (screws & plate) that was used was manufactured by nexxt spine.Images taken during my first follow-up post-surgery showed everything was correct and no problems were present.Likewise, all discomfort was gone and most numbing/tingling was gone as well.Some problems and discomfort began to arise over the past year or so, and i therefore decided to see a neurosurgeon recently in order to request an mri, ct and x-ray.All images and accompanying reports have revealed two major problems.First, both titanium screws in my c6 vertebrae are broken in half inside the bone.Second, the safety mechanism designed to prevent the screws from backing out has failed, resulting in the screw protruding outward by 4 to 5 millimeters.If this were just one failure it could, maybe chalked up to a fluke, but there are three failures occurring here simultaneously, and i am consequently faced with a very bad situation and risky decisions involving the cervical spine, not to mention the stress and discomfort.Fda safety report id# (b)(4).

• Brand Name: 66MM 3 LEVEL PLATE, 18MM VST SCREW, 16MM VST SCREW, 18MM VSD SCREW
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): NEXXT SPINE LLC
• MDR Report Key: 10282677
• MDR Text Key: 199308142
• Report Number: MW5095543
• Device Sequence Number: 1
• Product Code: ODP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 31-3-66, 31-8-4018, 31-8-4016
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 70