INFUSE BONE GRAFT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-14 for INFUSE BONE GRAFT manufactured by Medtronic.

Event Text Entries

[26175223] I started the process of dental implants and one of the implants became infected. The implant was in a piece of thin bone and on (b)(6) 2015 the jaw bone fractured at the infected site. On (b)(6) 2015 i underwent surgery to repair the fracture. I understood i would donate my own bone graft from my hip and that is what i signed a release for, alone with titanium plate and screws. When i woke from surgery i had severe edema of my face, neck, and mouth along with pain. I was discharged the next day even though i asked the doctor's fellow if i was having some kind of unusual reaction. He told me dr (b)(6) had done something different and that is why i had the edema, and it was expected. There was no need to stay any longer as i was not having complications and procedure did not require further hospitalization. By the next day at home i developed severe headache and stomachache. (the headache and stomachache lasted without ceasing for 4 weeks). The headache and stomachache now come and go. The edema in my face lasted for 4 weeks. I still have edema in my neck. My next visit to see dr (b)(6) was on (b)(6) 2015. He explained i was ok, did ct scan and told me i had no airway obstruction, i was feeling pressure from the fluid. He explained to his resident and his fellow this was expected due to the bmp. I did not understand until i received my medical records that i received an implant. Infuse bone graft, for which i had no knowledge of and had not given permission for dr (b)(6) to implant. I have gained 9 lbs of generalized edema. On (b)(6) 2015 i continued feeling "bad" and still had edema, headache and stomach pain. I went to er. I saw dr (b)(6) the next day. I have joint pain in my hips, shoulders, elbows, and hands. On (b)(6) 2015 dr (b)(6) did ct scan and told me i still had fluid in my neck that would resolve in 3-4 months. I am weak and have episodes of extreme weakness when i change positions. My local doctor has done blood sugars which are now elevated as well as my blood pressure. I have had changes on stress test which shows increasing severity of pulmonary hypertension. I have been put on viagra for this. My breathing problems continue and my pulmonologist increased the setting on my bipap/ventilator at night. My nephrologist told me i should report this to fda. Reason for use: repair fx. Event not abated after use stopped or dose reduced.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5056205
MDR Report Key5084762
Date Received2015-09-14
Date of Report2015-09-14
Date of Event2015-07-15
Date Added to Maude2015-09-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameINFUSE BONE GRAFT
Generic NameINFUSE BONE GRAFT 2.8CC
Product CodeNPZ
Date Received2015-09-14
Lot NumberM111404AAN
ID Number7510200
Device Expiration Date2017-03-01
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2015-09-14

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