MAUDE Adverse Event Report: SKULL PLATE; BONE PLATE

Device Problem Break (1069)

Patient Problems Unspecified Infection (1930); Visual Impairment (2138); Numbness (2415)

Event Date 02/15/2011

Event Type  Injury  

Event Description

I developed brain cancer in my right frontal lobe, found in (b)(6) 2011.The doctor was inserting screws to my skull bone.He tightened one of the screw and it broke so the surgery went longer.I developed an infection with radiation on the area of my previous surgery and the dehisced extending my radiation treatments, these 36 radiation treatments made me very sick.I had to have an emergency surgery to see what was going on in my brain.This surgery revealed that my skull bone was infected and they removed 1/4 or more of my skull and used more screws than they anticipated.I had some kind of infection prior to this and had drains in my head to get excess fluid out of my swollen brain.After this surgery i developed another infection and another hospital stay.Throughout the whole ordeal of dealing with this situation i had six to eight infections, and at least three to four stays in the hospital, some up to 2 weeks.I am not sure what the name of the plates were or what the company was called for these (i have all my notes from this time, i could look through notebooks and files for a day, to find this out).The last surgery i had was to insert a vagus nerve stimulator, vns made by cyberonics, this also became infected and i had yet another surgery and infection.They had to redo the surgery on my right chest instead of my left.The specific company for the vns was made by cyberonics with generator (b)(4).After this surgery i had to stay one night in the hospital.I moved to (b)(6) to be near my sister who helped me out.The trip from (b)(6) is 45 minutes as opposed to 3 hours.On one trip from (b)(6) i totalled my (b)(6), i don't remember why.Some of the leftover symptoms are: i have not worked since 2011 in a job i loved as (b)(6); i have really bad balance and numbness on my left side, i go to the hospital at (b)(6) every 4 months to get a contrast mri with the neurosurgeon and with a neurologist to check and adjust my medication if needed.I cannot use a ladder, cannot swim alone, cannot kayak or canoe with my family, i cannot snowboard with my girls anymore, occasionally i lose my driver's license for medical reasons.So that is my story.One thing to add is that along the way someone snagged and paralyzed one of my vocal cords, it will remain that way for the rest of my life.After all this happened, my eyesight changed, i never had to use eyewear until after all this.Thank you, and if you need anything further, please feel free to call me (b)(6).I am not sure my cognitive abilities will ever be the same.

• Brand Name: SKULL PLATE
• Type of Device: BONE PLATE
• MDR Report Key: 5529168
• MDR Text Key: 41371874
• Report Number: MW5061274
• Device Sequence Number: 3
• Product Code: JEY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2016
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 52 YR
• Patient Weight: 91