MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SPF SPINAL FUSION STIMULATOR; STIMULATOR, INVASIVE BONE BROWTH

Device Problems Material Disintegration (1177); Nonstandard Device (1420)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Date 09/12/2012

Event Type  Injury  

Event Description

In 2010, i had cervical fusion completed.In 2012, i had a lumbar fusion, the hardware in my back was made by biomet.I am highly allergic to cobalt/nickel.I haven't been out of pain, or able to work since.The neurosurgeon who performed the surgery was very well aware of my nickel allergy.He reassured me and my husband that he had researched the hardware, and that it was titanium.I was lucky enough to get the component break down.The hardware has nickel within it.I'm frustrated as well as many i'm sure.The shoulder hardware has been recalled, hip as well.Now they are getting sued yet again for their spinal cord stimulators.This is insane.I have a stimulator, it doesn't help.It was stated in my last mri that metal was flaking off of the hardware.I believe i have 6 pedicle screws on each side, 4 plates, and 2 connector rods.This is no where close to what i was told.My health continues to get progressively worse.Please help me.Contraindications, the polaris 5.5 spinal system is contraindicated in pts with spinal infection or inflammation, morbid obesity, mental illness, alcoholism or drug abuse, pregnancy, metal sensitivity / foreign body sensitivity, pts with inadequate tissue coverage over the operative site or open wounds local to the operative area.

• Brand Name: SPF SPINAL FUSION STIMULATOR
• Type of Device: STIMULATOR, INVASIVE BONE BROWTH
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.
• MDR Report Key: 7956131
• MDR Text Key: 123668457
• Report Number: MW5080455
• Device Sequence Number: 2
• Product Code: LOE
• 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: 10/06/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 46 YR
• Patient Weight: 82