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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28 PLATE; PLATE, FIXATION, BONE

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PARAGON 28 PLATE; PLATE, FIXATION, BONE Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problems Rheumatoid Arthritis (1724); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Rash (2033); Blister (4537)
Event Date 06/17/2021
Event Type  Injury  
Event Description
On (b)(6) 2020, i underwent surgery on my foot.I expressed concern about metals in my body, explaining that i'd had blistering rashes from costume jewelry earrings in the past.My surgeon said the hardware she would be using was made of titanium, and no one is allergic to titanium.Nine months later, i developed inflammation and a blistering red rash on my foot, initiated in all areas where hardware had been implanted.The rash spread quickly.The hardware was removed on (b)(6) 2021; 10+ months after it was implanted in my foot.Eleven days later, on (b)(6) 2021, i was diagnosed with rheumatoid arthritis (ra), that included extremely high levels of ra factor, equalling 813.In her office visit clinical notes, my surgeon stated that i attributed the blistering rash to new pillows i was using.I did not.The pillows are hypoallergenic.I used them for both feet at the time, but the foot with hardware was the only one with a rash.I have continued to use these same pillows now for my feet, knees, and arms (as i side sleep often) for more than two years with no rash anywhere except in the foot that had hardware in it, and only when the hardware was in it.Once the hardware was removed, the rash did not return (until more metal implanted).A dermatologist attributed the rash to tea tree oil, but i was using the vitamin e and tea tree oil on both feet.Again, only the foot with oil had the rash and inflammation.In her (b)(6) 2021 operative notes, my surgeon documented "painful hardware" as the reason the hardware needed to be removed, but i never complained of pain because there was none.Nine months after the hardware was removed from my foot, my ra factor had decreased by 36% to 517.On (b)(6) 2022, i needed another surgery on my foot, unfortunately, i had to have metal hardware for that procedure because i needed a plate, not just screws, and non-metalic plates do not yet exist for orthopedic surgery.By early (b)(6) 2022 (7.5 months later), i again started to get a rash and inflammation in the area where that hardware was implanted.(i had not used the tea tree oil since early 2021.) my ra factor had also increased by 10% to 568.When a different surgeon removed that hardware on (b)(6) 2022, that surgeon also documented the reason for hardware removal as "painful hardware", despite my informing him on numerous occasions that i needed the hardware removed due to an allergic reaction in the past.He even noticed the red spots and inflammation in my pre-operative visit.I believe that many surgeons are misreporting metal "allergies" as "painful hardware".As a result, many other doctors refuse to believe patients like myself when they say they have allergies to metals.This misreporting likely goes on in most cases without patients realizing it, as most of us never bother to ask to see clinical and operative notes.I never did myself until recently.Not once, but twice a metal allergy was misreported as painful hardware for me alone.And it was done by two completely different doctors in two different practices.When i emailed my most recent doctor, asking why it was documented as "painful hardware", i received no reply.I suspect doctors are either concerned that insurance will not pay for the hardware removal procedure otherwise, or they are covering for one another.But it concerns me that many other patients, like myself, will not be believed when they express concerns about metals.And with little reporting of allergies, there is minimal interest in developing safe alternatives so patients like myself do not have to go through extra surgeries and the expenses, risks, and complications that come with same.Please do what you can to make sure metal allergies are accurately reported in the medical field.And please encourage alternatives such as ossiofiber (which i now have).Note: no pic of recent hardware because my surgeon never got the message that i wanted it.Problems occurred two out of two times when device used: once in 2021 and again in 2022.Paragon titanium alloy hardware caused the problem: blistering rash and inflammation; and it triggered then exacerbated autoimmune disease (rheumatoid arthritis).(for more details, paragon 28 allergy report which was sent to me by a paragon rep after allergic reaction occurred.) one last thought just came to mind as to why doctors won't report hardware allergies: is it possible that they don't report it because they make a lot of money when using the metal hardware, and/or does the manufacturer provide then with big kickbacks (commissions)? "hmmm" frankly, i don't really care why they do it.I just want it stopped so patients like myself don't have to suffer unnecessarily as i have.On (b)(6) 2022, i had to have surgery to remove paragon 28 titanium alloy hardware removed from my foot due to an allergic rash and inflammation.This was the second time i have had to have such a surgery.
 
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Brand Name
PLATE
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
PARAGON 28
MDR Report Key16379085
MDR Text Key309652767
Report NumberMW5114930
Device Sequence Number5
Product Code HXI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/11/2023
6 Devices were Involved in the Event: 1   2   3   4   5   6  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/14/2023
Patient Sequence Number1
Treatment
CHONDROITIN; GLUCOSAMINE; GLUTATHIONE; MULTIVITAMIN; OMEGA 3'S; ORGANIC/FOOD BASED SUPPLEMENTS; PROBIOTICS; R-LIPOIC ACID; RESVERATROL; TURMERIC; WHITE FISH SUPPLEMENT WITH BOSWELLIA (INTESTIVE).
Patient Outcome(s) Disability; Other;
Patient Age60 YR
Patient SexFemale
Patient Weight66 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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