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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. RHBMP-2; FILER RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN

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MEDTRONIC SOFAMOR DANEK USA, INC. RHBMP-2; FILER RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN Back to Search Results
Device Problems Break (1069); Leak/Splash (1354)
Patient Problems Abdominal Pain (1685); Patient Problem/Medical Problem (2688)
Event Date 01/08/2015
Event Type  Injury  
Event Description
I endured a third revision of 2 previous spinal fusions on (b)(6) 2015.A/p bilateral discectomy l4/5 (l5/s1 previously fused (b)(6) 2010).During this invasive procedure (l4/5) acs with rhbmp-2 was administered.During surgery the peek cage was broken and remained this way for 72 hrs or until (b)(6) 2018 when another revision / emergency surgery was endured at l4/5; 3 weeks post-op i returned to the same hosp with low left abdominal quadrant pain.Ultrasound confirmed a mass/fluid.Biopsy inconclusive.I believe this was rhbmp-2 that leaked from the broken peek cage and has now spread through my body.I have recently been tested for cancer, hepatitis, autoimmune.All ruled out thus far.I believe i fit the adverse effects in various "thesis" within the national library of medicines.I am currently attending anesthesiology, hematology, neurosurgery, rheumatology.Please provide any insight.Thank you in advance, (b)(6).
 
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Brand Name
RHBMP-2
Type of Device
FILER RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC.
MDR Report Key8151040
MDR Text Key130099085
Report NumberMW5082004
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 Patient
Type of Report Initial
Report Date 12/08/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/08/2015
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 Age30 YR
Patient Weight80
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