MAUDE Adverse Event Report: K2M, INC. EVEREST SCREW SYSTEM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number HSS WOULDN'T PROVIDE IT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arthritis (1723); Inflammation (1932); Itching Sensation (1943); Nausea (1970); Pain (1994); Burning Sensation (2146); Tingling (2171); Cramp(s) (2193); Hernia (2240); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Abdominal Distention (2601); Constipation (3274)

Event Date 05/21/2018

Event Type  Injury  

Event Description

Rods and screws implanted in my spine l4-s1 during a spine fusion performed on (b)(6) 2018 by dr (b)(6) at the (b)(6) destroyed my body.He had diagnosed me with grade 1 spondylisthesis, stenosis, and spinal decompression.I have been incapacitated for the past 16 months since the surgery.Before the surgery, i had severe pain in my low back, right hip, and going down my legs.Since the surgery i have been in excruciating pain - much worse pain in more parts of my body than before the surgery.I was told that i'd be able to return to dancing and performing - my lifelong passion - a year from the surgery.Instead, i have no longer been able to eat, stand, walk, lie down, or sleep without incredible pain.I developed numerous biological responses, including a blood transfusion, gi conditions (ileus, chronic constipation - so severe that i cannot move my bowels at all, even with multiple laxatives a day, except with a fleet enema despite treatment by an expert gastroenterologist.Small intestinal bacterial overgrowth - sibo, chronic constipation, severe bloating, nausea, cramping, ibs, gerd, gastritis, hiatal hernia.Immunological conditions diagnosed by an expert rheumatologist (seronegative arthritis, spondyloarthropathy, inflammation), and excruciating pain - in my low back, mid back, upper back sacrum, glutes, pelvis, hips, feet, legs - ranging from feeling like a sheet of metal is being pressed into my low back, mid, upper back, sacrum, hips, glutes, and pelvis - like a metal corset, to mid and upper back spine compression, to prickly needles in my hips, sacrum, and groin, to throbbing, pulsating, aching pain / inflammation like electrodes on high voltage throughout my whole body/ system particularly my feet and legs, to burning and itchy eyes, to shaky, tight, pulsating hands, to burning legs, to pain when lying on my arms.Post surgery i was also diagnosed with hip impingements on both hips, femoral anteversion on right hip, sp;ine, pelvic, core syndrome by an expert orthopedic surgeons.It has been an absolute nightmare.(b)(6) did not help me address the failed spine surgery.Nevertheless, many months later, i asked to meet with a pt advocate at (b)(6) in (b)(6) 2019 begging for help and a meeting / treatment, recommendations with drs from various specialities.About a dozen (b)(6) drs met with me once, but did not view the medical imaging that was done at the time that i provided, did not examine me, and did not ask meaningful questions.Instead, they spit balled a few ideas, including some that contradicted each other and provided no f/u except a month later giving me info about water therapy, which i had already started elsewhere.At the meeting, my surgeon said maybe i should take the metal screws and rods out, but didn't mention why and any tests to determine whether removal would alleviate my symptoms.The rheumatologist at the meeting said i didn't have systemic conditions, but a rheumatologist at (b)(6) subsequently did testing and an examination and diagnosed me with seronegative arthritis and spondyloarthropathy.The (b)(6) rheumatologist has tried various medications, including humira, methotrexate, prednisone, and most recently cosentyx, but i am still suffering tremendously.I need to constantly change my position because of the horrific pain.I typically can't walk more than 1/2 mile without such excruciating pain that i need to sit for awhile.I am desperate for help.I will be testifying at the fda advisor committee hearing on immunological responses to metal device implants and look forward to better testing, studies, treatment, and consumer protections as soon as possible for myself and the thousands / millions of others.(b)(6) never notified me about the fda warning about biological responses to metal devices issued in march 2019 or the fda hearing.I recently discovered this critical info on my own.Feel free to contact me.Fda safety report id# (b)(4).

Event Description

Add'l info received from reporter on 11/14/2019, for report number mw5090760 to add address.

• Brand Name: EVEREST SCREW SYSTEM
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): K2M, INC.
• MDR Report Key: 9255288
• MDR Text Key: 164664036
• Report Number: MW5090760
• Device Sequence Number: 1
• Product Code: MNH
• 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,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HSS WOULDN'T PROVIDE IT
• Device Catalogue Number: HSS WOULDN'T PROVIDE IT
• Device Lot Number: HSS WOULDN'T PROVIDE IT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 51