Patient called to report a product issue and adverse event she experienced during a kyphoplasty procedure she had on (b)(6) 2021.Patient stated after the procedure she felt like a nail was going through her vertebrae, through her spinal column, and pushing through the top of the spine.Patient stated she was referred to a surgeon to assess the bulge on her neck and they ordered an mri which showed pieces of bone cement in her spinal column.Patient learned online of a recall of a bone cement injection device and is concerned that could be what was used during her procedure.She stated she has a large bulge on her neck and had trouble swallowing, weight fluctuation, cervical stress fractures, and hair failing out.Patient stated she can¿t lean against the bulge on her neck and was told by a doctor that it appears to be inoperable.She said she was told she could become paralyzed at any moment.Reference report mw5144910.
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