FDA Adverse Event Injury Summary report: N

INFUSE BONE GRAFT

MDR report key: 5084762 · Received September 14, 2015

Report

Report Number
MW5056205
Event Type
Injury
Date Received
September 14, 2015
Date of Event
July 15, 2015
Report Date
September 14, 2015
Manufacturer
MEDTRONIC
Product Code
NPZ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
MS, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
605388 INFUSE BONE GRAFT INFUSE BONE GRAFT 2.8CC NPZ MEDTRONIC M111404AAN

Patients

Seq Age Sex Outcome Treatment
1 62 YR Hospitalization