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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY NO INFORMATION IN RECORDS AND BILLING; ANTERIOR INTERBODY LUMBAR CAGE

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DEPUY NO INFORMATION IN RECORDS AND BILLING; ANTERIOR INTERBODY LUMBAR CAGE Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Component Missing (2306); Cut In Material (2454)
Patient Problems Pain (1994); Test Result (2695)
Event Date 01/15/2015
Event Type  Injury  
Event Description
Back in 1995, i had an anterior interbody lumbar fusion and i filed an adverse event in 1996/1997 and you sent an investigator out and he contacted me by phone and went in person to see the doctor and if your investigator would have actually looked at my x-rays and file, he would have seen that my cages in my spine have no end rings in each end and no screws to anchor the cages in place, the cages are packed in bone graft material and the cages show up on x-rays but the "gs" and screws made of same metal do not show up because not there, just noticed this a few days ago going thru papers with a neighbor.My other thing is the bone graft recalls, i have like 4 symptoms on the list and when you look at my surgery and detailed medical billing, your investigator should have seen that in these notes, there is no serial numbers for the cages, rings or screws and that's because the rings and screws were never used and the rings, the doctor cut each end off, thus eliminating the serial numbers.When this surgery took place, depuy's web page stated, in order for any doctor to implant any of depuy's implants, you had to be trained by them and then authorized to be on their certified doctors list and if not on list, you would be denied access to buying or implanting any of depuy's implants and if your investigator would have checked it out, this doctor was not on that list and should have never been allowed access to these cages and hardware and somehow he did and these were only approved for facial reconstructive surgery for facial bones because they don't bend for use only in europe and not in usa and there had never been an application for a study program as well as never being approved by fda back then.I know now that if this surgery was on the truth as well as the investigation from fda, i would have been sent a little medical device implant card, that would be issued from depuy, that would have date of implant, doctor's name with phone number, type of implant and serial numbers, i never received one of these.I eventually had to get a morphine infusion pump implanted into my lumbar area of my spine because of these cages.And now have electric nerve stimulator implanted into same place of my spine, which i received a medical implant card for everytime something changed with the morphine pumps and one for the nerve stimulator implant, which they have serial numbers, implant dates and doctor who implanted it and manufacturer information on device.I have had a disabling situation from these cages and bone graft issues and besides the nerve stimulator implant, i am on a lot of morphine meds i take now and another regimen of pain pills, anti-inflammatories, sleeping pills, and clonidine to keep heart rate down when i have severe pain from cages and bone graft areas and a few other rx meds to deal with it, 8 different meds a day and only takes off a small portion of pain, there's never a day of being pain free.I feel like your investigator either didn't want to do his job or was paid to side with the doctor and basically screwed me by not doing his job honestly.He told me that because he is a doctor, he don't have to let me know what he put in my body and it don't have to be in a study program or approved by the fda because it's medical research and that's a lie, which i just found that out a few days ago.This doctor has used same cages after me and one patient died after being discharged from hospital from complications from cages and another one, the cage fell out of place in the spine and wedge itself between the abdominal and intestines and he had no "reproman" from medical board no suspension or not even a ding on his record.I expect another investigation with a supervisor and an honest one, and be very thorough because i know your other investigator was wrong by what and how he handled it.You have 2 weeks and then i file suit papers and media will know what was done to me for your agency.(b)(6).
 
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Brand Name
NO INFORMATION IN RECORDS AND BILLING
Type of Device
ANTERIOR INTERBODY LUMBAR CAGE
Manufacturer (Section D)
DEPUY
MDR Report Key4450467
MDR Text Key20752466
Report NumberMW5040344
Device Sequence Number1
Product Code MAX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/18/2015
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/18/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Age49 YR
Patient Weight72
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