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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PLATE, FIXATION BONE

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PLATE, FIXATION BONE Back to Search Results
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Defective Component (2292)
Patient Problems Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Pain (1994)
Event Date 06/01/2012
Event Type  No Answer Provided  
Event Description
I was involved in an accident on (b)(6) 2012 which left me horribly injured.I sustained the following: broke every rib (some multiple) on the left side of body; left lung was punctured and collapsed; sustained compound fracture to left arm to include hand bones (left), requiring plates and screws, compound fracture at left arm elbow requiring 2 plates, screws and titanium wiring, and shattered my left rotator cup.(screws).I was airlifted to (b)(6) hospital at (b)(6).Upon admittance to er, i was to undergo multiple orthopedic surgeries at (b)(6) facility under dr.(b)(6), md as surgeon.After intensive care of the arm and pulmonary system, i was then released from (b)(6) on or about (b)(6) 2017 with the understanding that all of the above mentioned "hardware" (screws, plates, wires, etc) were to remain an integral part of the damaged limb "for a lifetime." i was released from care w/approximately 4 hours of rehab and never scheduled for any rehab appointment.I did however continue w/wound aftercare at the trauma aftercare unit in the same building (2nd floor) under the care of a dr.(b)(6).I saw him multiple times over the next 90 days, always at 5:00 am - 6:00 am and always with x-rays.I was never referred, sent or asked about physical therapy/rehab.At the end of our time, he told me: a "hardware" were to remain for my natural life; told my range of motion (less than 50 percent) was complete/may improve; released to life and work as i found it/ knew it.(no counsel).Released, and despite multiple attempts, have never seen him again.In (b)(6) 2014, i began to experience pain and fever in the left elbow (usually at night) and an occasional puss pocket".I called dr.(b)(6), left numerous messages to no avail.No returned calls.So, these "puss pockets" (let's just call them abscesses) continued, but i also noticed the frequency of healing time was shortening.I would get as many as 3 at a time (always in same locations), i would simply "pop" them with a knife or toothpick, squeeze it, drain it.It would scab, heal, and go away for a while, only to return.I called (b)(6) again.Nothing! i began working out of state with hansen-rice, and the fever and the infection went to work with me.During (b)(6) of 2015, hanging the (b)(6) lights on my home, i began experiencing excruciating pain in the left elbow.It was very tender and when it came into contact with anything the pain exploded.I called (b)(6) again.Nothing.No return on my calls.I had to actually change up my sleeping routine/positions in order to rest at night.I was then invited to a (b)(6) er by the office (snotty attitude emphasized).In ( b)(6) 2016, (b)(6) records will indicate that i did visit an er at their facility on (b)(6).The "abcesses" and pain were still ever with me.At this hospital, i was treated and released for: low grade fever/infection in the left elbow; x-ray reveals one break in titanium wiring; culture shows (b)(6) infection in elbow.After 2-3 weeks, the "puss pockets" still present, i visited mission trails baptist hospital and was told: low grade infection/ fever present (had not cleaned up); again, the wounds were "purged" of puss (a painful process); after "bleeding the wound", he confirmed the fever/infection to records.After the visit, the "abcesses" never healed again and were always emanating or "oozing" a yellow puss and festering at all times.However, by now, it had gotten so bad that family, friends and even the public began to comment.I treated this with aleve and copious amounts of beer.Moreover, i daily placed/replaced bandages (3.74 at (b)(6)) on the wound to obscure it from public view.This self-administration of care continued until (b)(6) 2017, when i could no longer bear it! the pain, irritation, lewd remarks and lack of sleep.The pain! i returned to (b)(6) only to be seen by the same physician as the year before, who: x-ray revealed now two breaks in titanium wiring at elbow; low grade fever present; (b)(6) infection in the elbow.On (b)(6) 2017, i appeared at orthopedic aftercare (not trauma aftercare), where more x-rays were done, and dr.(b)(6) confirmed: (he and one of his staff concurred): culture of infection was (b)(6) in nature; no medicine would serve to fight the infection; i was told (verbatim) "the hardware" is the source of infection"; the "hardware" would have to be removed.The dr and staff now explained to me in great detail that in order to eliminate the infection the elbow would have to be re-opened, hardware removed, the area "debrided" (deep scrubbing), antibiotics would then be "packed" into the wound to eliminate/ eradicate the infection; i was told all hardware plates screws wires were to be removed for success; i was told after infection was controlled 2 other operations (hand/rotator cups) would need to do the same thing.He adamantly told me that in order to eliminate the change or reoccurrence of infections, that all of the hardware needed to be removed.So we were talking about 3 more surgeries.We set a tentative date for the elbow in (b)(6) 2017.So, as a resident of (b)(6), receiving wound care for both a wounded knee (which also required another surgery), and from the daily bandage or dressing changes on my infected elbow, i spoke daily to medical staff about the procedure (to no avail on the knee), but finally, in an effort taken all on her own, and in violation of doctor's orders on the care/prognosis of the arm and wound care, olga ali needlessly forever maimed me when she "lanced" the elbow in three different areas, one of which was about the size and consistency of the removal of flesh (w/o sutures) of size, shape and depth of a marble, leaving a "crater" in my arm.This was her idea to circumvent a requested and scheduled orthopedic procedure.This caused no undue amount of pain (not withstanding the scar) in her actions to render a "less efficacious treatment" of the injury in deliberate indifference to the prescribed medical treatment by a fully licensed vested and practicing physician of orthopedic surgery.Finally, after a 3rd letter (detailing the aforementioned outrage), to dr.(b)(6), i was taken to an mri appointment and days later to surgery at the main hospital on (b)(6) 2017 wherein dr.(b)(6), removed only some of the "hardware", to include a 4.5 inch screw, 2 pieces of broken/knotted titanium wiring, debrided the wound, and packed w/antibiotics to kill the infection.Thus the fact the defective implants were removed.(b)(6), three weeks later at the appointment to remove the sutures, informed me of his decision of reversal of previous decision to remove all of the "hardware".However, he remained adamant in removal of hardware from rotator cup and "scope" the rotator cup to eliminate any chance of infection, to remove a screw which is working it's way out of the arm, and possibly enhance range of motion.This was (b)(6) 2017.So, what constitutes immediately.It is still not done.A knee damaged/injured on (b)(6) 2017 and prescribed for the orthopedic surgery on (b)(6) 2017, by staff and transfer request as generated by (b)(6) staff to (b)(6) staff in (b)(6) 2017.
 
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Brand Name
PLATE, FIXATION BONE
Type of Device
PLATE, FIXATION BONE
MDR Report Key7600628
MDR Text Key111384391
Report NumberMW5077853
Device Sequence Number1
Product Code HRS
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 06/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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