MAUDE Adverse Event Report: BIOMET SPINAL PAK

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Local Reaction (2035); Vertigo (2134); Dizziness (2194); Therapeutic Response, Decreased (2271); Test Result (2695); No Code Available (3191)

Event Date 08/28/2014

Event Type  Injury  

Event Description

Skin reaction to the electrical pads.Growth of a tumor where the pad was used.Tumor wrapped around my carotid artery and may have caused vertigo and ringing in my ear.I needed surgery to remove the tumor, which may grow back.After cervical infusion for c-4 thru c7, i was given a spinal pak by biomet.This is a bone growth stimulator.After just one day of wearing this device, i began to have a skin reaction under the pads due to the "sticky" backing.I ordered a 3m product called cavilon, which protects the skin for those who must use medical products on a long term basis, e.G.Colostomy tubes.It allowed me to wear the bone growth stimulator for 24 hours, seven days a week for four months.A few weeks after i stopped wearing the device i began having an increase in my lymph count on my blood count results.I also began having dizzy spells (vertigo) and ringing in the ears as well as vision problems.I saw a neurologist who thought i had myasthenia gravis.I also went to the eye doctor who found that i had double and blurred vision and agreed with my seeing the neurologist.We tried two prescriptions and i had a brain ct and mri to rule out a thymoma or other ear or brain problems.My lymph count continued to rise.My rheumatologist finally told me to have my lymph node biopsied.When my surgeon opened my neck to remove the node, he found a warthin's tumor wrapped around my carotid artery and attached to the salivary gland on the right side of my neck/jaw.These tumors are usually found in males who smoker or chew tobacco.I have never done either one.Presently i am waiting to see a doctor at (b)(6) medical center in (b)(6).I am starting to think i may have another tumor on the left side of my neck where the other pad was placed.If so, i will need another surgery.Meantime the fusion i had on my cervical spine seems to have failed.

• Brand Name: SPINAL PAK
• Type of Device: SPINAL PAK
• Manufacturer (Section D): BIOMET
• MDR Report Key: 4270877
• MDR Text Key: 5229934
• Report Number: MW5039212
• Device Sequence Number: 1
• Product Code: LOE
• 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: 11/10/2014

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: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2014
• Patient Sequence Number: 1
• Treatment: FISH OIL CAP; VITAMIN D, 2000 UNITS PER DAY
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 71 YR
• Patient Weight: 102