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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK MEDTRONIC INFUSE BONE GRAFT
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MEDTRONIC SOFAMOR DANEK MEDTRONIC INFUSE BONE GRAFT Back to Search Results
Device Problem Human-Device Interface Problem (2949)
Patient Problems Pain (1994); Deformity/ Disfigurement (2360); Reaction (2414); Test Result (2695)
Event Date 09/06/2013
Event Type  Injury  
Event Description
The surgeon that performed my 3-level cervical discectomy and fusion surgery used the medtronic infuse bone graft product (x3), knowing that it was banned by the fda in use in cervical spine surgery.He told me that the new discs would be from a bone bank from a cadaver only.I have tremendous pain now and already have bone spurring of the areas where the surgery was performed.I feel like he lied to me and used a product that, according to the research i've done since then, didn't even produce good to better results than just using cadaver bone to begin with.I don't have any idea what i will be facing in the future in terms of additional problems.My husband is retired and i am the sole supporter in our household.I am furious that he did this to me, and that the "surgery center" allowed it.I also learned that he is an owner of the facility; that explains why i was told that i needed to have the surgery there, and not at the hospital where his offices are located.
 
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Brand Name
MEDTRONIC INFUSE BONE GRAFT
Type of Device
MEDTRONIC INFUSE BONE GRAFT
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK
MDR Report Key5064193
MDR Text Key25361649
Report NumberMW5056040
Device Sequence Number1
Product Code NEK
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Report Date 09/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/03/2015
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age49 YR
Patient Weight65
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