MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Encephalopathy (1833); Unspecified Infection (1930); Pain (1994); Swelling (2091); Vomiting (2144)

Event Type  Injury  

Event Description

It was reported that the patient was hit in an auto/pedestrian mva.One year after the mva, two spine injuries had not healed.Patient presented to surgeon who reportedly told him that the l3-4-5-s1-2 bones had not healed.Patient underwent multiple fluoroscopically guided injections.On june 1 (no year provided) the patient underwent an ¿inner and outer fusion¿ at l3-4-5 and s1-2, as well as a laminectomy and compression.Patient reported that the surgical approach was axially.Surgeon reportedly used hardware, 3-inch pedicle screws, rods, and 10 ¿titanium bone baskets¿.On post-op day 3, the patient reports that he began having hallucinations, delirium, screaming, vomiting, and violent diarrhea fits.In 15-30 minutes the patient reports having a fever of 105.Two hours later, he reports that his fever was 107f.Patient reports having toxic encephalopathy of the brain, bleeding from eyes, nose, and ears, kidney failure, liver failure, and heart failure.Patient reports having permanent brain injury, losing 10-15 years of memories.Patient does not ¿know or like¿ his wife of 30 years, his child, or two of his sisters.Patient reports personality changes, permanent nerve damage, shaking, and shivers down his spine.Patient reports pain, sleep deprivation, bone pain, ¿wondering legs¿ and aching in his arms, legs, and hands, swollen fingers, and foot spasms.Patient reports that on post-op day 4 the surgeons ¿opened top of my head to put nitrogen rods to reduce brain swelling¿.Patient reports vision loss, hearing loss, permanent brain damage, nerve damage, ¿no sexual feelings, penis is dead, dry no ejaculation, bladder, prostate, penis blockages 2005, 2006, 2007, 2009, 2012, all needing surgery¿.Patient reports having cancer found in 2006, 2007, 2009, and 2012.All cancers were reportedly identified as non-descript or non-specific.Patient reports having an ng tube and ¿massive bowel-gut¿ ileus.Patient reports double pneumonia, requiring two tubes in his lungs.Patient states that his lungs were leaned while he was in a coma, and he never smoked again.Patient reports on post-op day 10 that ¿they filled me full of some anti poop meds then put me in an ambulance and shipped me to a dungeon to die, i walked out of the dungeon in 21 days with a walker.¿ patient reports pain from s1 up through the cervical spine, thoracic pain through shoulders, down arms to fingertips, down legs with burning through the hips.His feet cramp at night.Patient takes 1250 mg of oxycodone and/or hydrocodone every 8 hours.On (b)(6), patient presented for followup.Blood work reportedly showed elevated liver tests (from normal under 50 up to 1450).Patient was admitted to the hospital.Patient reports having penis, bladder, neck, and prostate cancer.Patient reports having nondescript cancer three times in 2007.Reportedly, the patient required reparatory surgery after having the cancer removed from the penis.In (b)(6) 2012, a colonoscopy found 3 cancerous polyps which were removed and identified as non-descript cancer.Patient reports having trouble eating, the food would get stuck in his stomach and require surgery.Patient reports that his device implant dna is ¿killing my inner workings of stomach-small intestine made it morph-die causing 30 plus spots to be dead, paralyzed, ½ in up to 4 to 5 inches.¿ patient reports only being able to eat greek yogurt.Patient reports bowel-bladder incontinence and partial paralysis of the stomach and small intestine requiring 11 surgeries.On (b)(6) 2013, patient was admitted to the hospital for ¿strangulated stomach-small intestine.¿ patient had surgery to remove a 19x17cm tumor, and then a ¿redo¿ of his stomach.Patient reports having bone overgrowths in the following locations: 1 inch inside the bottom of the lower jaw, 4-6 inch circle in center of front of chest, in his back, in the center of the thoracic area, in the cervical area, inside the crotch, inside his pelvis, and in his feet.Patient reports having surgery on (b)(6) 2014 and waking up with ¿sweat and blood all over¿, and a dollar coin-sized hole in his chest.Patient reports being put on antibiotics on (b)(6) 2012, but that they did not heal his ¿medtronic type infection¿ and so he had to have surgery.Patient reports that his chest is still infected and he is still on antibiotics.

Manufacturer Narrative

(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4274451
• MDR Text Key: 19088470
• Report Number: 1030489-2014-04557
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2014

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2014
• Initial Date FDA Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention