MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-10 for POLARIS LANX PEDICAL SCREWS PEDICLE PREPARATION manufactured by Zimmer Biomet.
[123668457]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080455 |
| MDR Report Key | 7956131 |
| Date Received | 2018-10-10 |
| Date of Report | 2018-10-06 |
| Date of Event | 2012-09-12 |
| Date Added to Maude | 2018-10-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POLARIS LANX PEDICAL SCREWS |
| Generic Name | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM |
| Product Code | NKB |
| Date Received | 2018-10-10 |
| Model Number | PEDICLE PREPARATION |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET |
| Brand Name | SPF SPINAL FUSION STIMULATOR |
| Generic Name | STIMULATOR, INVASIVE BONE BROWTH |
| Product Code | LOE |
| Date Received | 2018-10-10 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET SPINE INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Deathisabilit | 2018-10-10 |