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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAK TITANIUM CAGE
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BAK TITANIUM CAGE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Physical Entrapment (2327); Disability (2371); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)
Event Date 03/25/2014
Event Type  Injury  
Event Description
In 1999, i had 2 bak cages put in my l5s1 area, for 3 mos i was good, then it all came back.All ct, mri's showed i had fused.A discogram was done.I had a failed fusion; a revision was needed.In 2005 one was done and that failed.Since these surgeries, i had 0 flexion limited motion and constant pain.I tried to have them removed.I was told by a surgeon, they cannot.The blood vessels "bbb" cling to the titanium.I also have leg pain, cannot sit, stand or walk for long periods since my surgery.Something is not right.I didn't have all of this before my fusion.It started after the surgery.These cages need to be further investigated to the max.I will have to live with constant pain, constant loss of mobility, it really has changed my life.It has taken yrs for me to accept this.If i knew then what i know now, i would have never had a fusion.I also had lucency of my cages and now due to a failed revision, a failed fusion i'm stuck with all this hardware and stuck with pain.
 
Event Description
Add'l info received from reporter on 04/10/2014: left thigh swollen numbness, nerve problems.Left thigh still swollen fusion failed required revision- 2005 revision failed- diagnosed degenerative disc disease.The remainder of the disc shattered.In 1999 a fusion was performed.I woke up in the hospital left thigh swollen, numbness - 3 months i did start feeling better when out walking a sharp pain shot across my back it made a sound and down my left leg.Test showed i had fused at least the ct myelogram it took me to 2005 to find a doctor to even look at my medical.He did a disco sram, no i did not fuse.He did a revision in 2005 that did not fuse.I live every hour in chronic pain and now the cages can't be taken out i want them out in 2005 the doctor said they can't.Through mri, ct scans, x-rays, disco sram, nerve condition test.This fusion has restricted my mobility, flexion back, sit, stand, walk limited.I wil have nothing but a life of chronic miserable pain.I assumed my doctor would have reported this; apparently not.I was on narcotics for 13 years.I stopped taking them.I soak in hot water.I take ibuprofen, aleve on a daily basis and at night two tylenol pain reliever nitetime sleep aides.I awaken between 2 am and 3 am with my lumbar in pain.These fusions are not for everyone.I have degenerative disc disease was told the fusion would help, well it didn't.Implant was put in (b)(6) 1999.
 
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Brand Name
BAK TITANIUM CAGE
Type of Device
CAGE
MDR Report Key3713086
MDR Text Key4263867
Report NumberMW5035332
Device Sequence Number2
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,Followup
Report Date 03/25/2014
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/26/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age34 YR
Patient Weight51
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