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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC INFUSE RHBMP-2
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MEDTRONIC INFUSE RHBMP-2 Back to Search Results
Model Number 173927
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Pulmonary Embolism (1498); Nerve Damage (1979); Pain (1994); Swelling (2091); Thrombus (2101); Disability (2371); Ambulation Difficulties (2544)
Event Date 05/12/2005
Event Type  Injury  
Event Description
Transverse/posterior approach decompression instrumentation spinal fusion of l3-s1 using medtronic's rhbmp-2 off-label has just been made apparent after 12 years of battling complications stemming from "failed back surgery," exploratory revision operation was done 5 weeks post-operatively on (b)(6)2005 and infuse was also used during this procedure.Complications ranging from permanent nerve damage and radiculopathy, ectopic bone growth, vascular damage leading to chronic dvt, post thrombotic syndrome.May-thurner syndrome resulting in stent placement, bilateral pulmonary embolism, chronic degenerative disc disease, pain and suffering, financial burden, decreased quality of life due to disability (pain, swelling, altered gait, and much more).
 
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Brand Name
INFUSE RHBMP-2
Type of Device
INFUSE RHBMP-2
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6732429
MDR Text Key80856256
Report NumberMW5071138
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 07/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number173927
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention; Disability;
Patient Age54 YR
Patient Weight104
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