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

Model Number 7510050

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problems Chest Pain (1776); Concussion (2192); Dizziness (2194); Anxiety (2328); Sleep Dysfunction (2517); Foreign Body In Patient (2687); Ischemia Stroke (4418); Malunion of Bone (4529)

Event Date 11/20/2019

Event Type  Injury  

Event Description

(b)(6) 2019: discover medtronic titanium pedicle screw at l4, screw head broke off and screw head lodged into muscle.Two different neurosurgeons call it pseudarthrosis or failed back surgery.(b)(6) 2022: discover on my own fda recall ref 7510050.What is the reason for why no one would contact me about the recall? (b)(6) 2022: revision surgery rescheduled until ct scan completed.(ct scan completed on (b)(6) 2022).(b)(6) 2022: appointment with dr.(b)(6) neurosurgeon a review of mri and ct scan images; dr.(b)(6) said there is very little bone growth on the left side from l4 down to s1, that's not good.Mri shows pressure between l3-l4 on the right side.Ct scan shows dislodged bone or bone-spur growth at l4 causing pressure on the nerves on the left side.Revision surgery scheduled for (b)(6) 2022.Please see other relevant history for detailed explanation.I have supporting documents and mri, ct, and x-ray images on disc.Other relevant history: (b)(6) 2017: i met with (b)(6), m.D.To review mri and discuss surgery option.I choose dr.(b)(6) for his minimal invasive approach and 1.5 hours in surgery.I had seen dr.(b)(6) for this surgery and his time under the knife was 6 hours minimum.(b)(6) 2017: 2 stage spinal fusion l4-l5 l5-s1 scheduled for 1.5 hours of surgery time, well it turned into 4 hours due to difficulties.(b)(6) 2017: i met with primary care and explain i stopped taking all opioid drugs approx.(b)(6) 2017 and i cannot fall asleep.I am staying awake 2/3 days at a time.Pc said i was feeling the side effects of opioid withdrawals.(b)(6) 2017: met with pc again because i am still having difficulties falling asleep and staying asleep.Pc said give it one more months and prescribed zolpidem 5mg.(b)(6) 2017: pc sends me to neurologist dr.(b)(6) because i cannot sleep.Dr.(b)(6) prescribed trazodone 50mg for 30 days.(no relief with medication) a.(b)(6) 2017: dr.(b)(6) increases trazodone to 100mg (no relief with medication); b.(b)(6) 2017: dr.(b)(6) changes medication to gabapentin 100mg (no relief with medication); c.(b)(6) 2017: dr.(b)(6) increased gabapentin 300mg (no relief with medication); d.(b)(6) 2017: dr.(b)(6) changes medication again to ropinirole 0.25mg and rozerem 8mg (no relief with medication); e.(b)(6) 2018: dr.(b)(6) said there is nothing else he can do for me and recommended mayo clinic.(b)(6) 2017: fainting event while out of town at a national sales meeting.Emergency room visit: ct brain, ekg ¿ i gave myself a head concussion.(b)(6) 2017: sleep study conducted ¿ paradoxal insomnia.(b)(6) 2017: my position as northeast regional sales director was terminated without cause.I have never lost a job in my entire life.Next 15 months unemployed with multiple health issues.(b)(6) 2018: i drive myself to the er with anxiety attack.(b)(6) 2018: mri of brain ¿ reduced blood flow to the brain "cerebral ischemia".(b)(6) 2018: er visit "hospitalized 3 days for sleep deprivation at the(b)(6).(b)(6) 2018: wife does not come home after work, and i do not know where she is.(b)(6) 2018: wife emails me asking me to move out of our marital home and to leave the (b)(6) area.Er visit with chest pains; i thought i was having a heart attack, but it was anxiety.(b)(6) 2018: wife and i file for divorce after 32 years of marriage.(b)(6) 2018: i schedule several counseling appointments at psychological associates before my scheduled appointment with dr.(b)(6).(b)(6) 2018: new patient at the (b)(6) clinic seeing dr.(b)(6), m.D.Psychiatrist, a follow up from (b)(6) 2018.(b)(6) 2018: wife hospitalized at the (b)(6) for suicidal thoughts.(b)(6) 2018: wife and i both drop the divorce.(b)(6) 2018: weekly marriage counseling with rev.(b)(6), phd., for 18 sessions.I have the mci's and ct scan from 2022 available, if needed.(b)(6) 2019: (b)(6) terminates my position without cause.(b)(6) 2019: i visit my pc because my right leg, around the knee area is numb, tingling, and feels like i have a sun burn on my right knee, but i have not been in the sun.(b)(6) 2019: nerve conduction study done on both legs.(b)(6) 2019: i visit my pc and mri gets approved and scheduled.(b)(6) 2019: mri leads to ct scan.(b)(6) 2019: x-rays of lumber spine.(b)(6) 2019: i visit (b)(6), dnp, agacnp-bc, rn, for(b)(6), m.D.She reports a review of the x-ray images displays screw cap broke off on the left side at l4-l5.She also reports i have a rock-solid fusion adhesion and it should not be a complication.(b)(6) 2019: i visit (b)(6), m.D.Neurosurgeon for a 2nd opinion.Dr.(b)(6) opinion is: "i think l4-5 is pseudathrosed and do not see much bone at l4-5.The left l4 screw cap appears loose.(b)(6) 2019: i visit dr.(b)(6) to discuss everything recently discovered.Dr.(b)(6) asked me about dr.(b)(6) visit, then tried to discredit everything dr.(b)(6) said.His plan, send me out for nerve injection shoots.(b)(6) 2020: telemedicine video visit with (b)(6), md(b)(6) hospital.After his review we discussed surgery options and spinal stimulator trial.Next visit scheduled.(b)(6) 2020: office visit with (b)(6), md (b)(6): mri review, discuss dx/tx right l4, l5 transforaminal epidural steroid injections, discuss referral for scs trial if symptoms don't improve.(b)(6) 2020: hospital visit for procedure, (b)(6) at the (b)(6) for lumbar epidural steroid injects.(b)(6) 2020: follow up phone call from dr.(b)(6).(b)(6) 2020: telemedicine video visit: schedule ct lumbar spine, fluoro ir myelo limbosacral w/lp.Fda safety report id # (b)(4).

• Brand Name: INFUSE BONE GRAFT X SMALL KIT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.
• MDR Report Key: 15606103
• MDR Text Key: 301941732
• Report Number: MW5112630
• Device Sequence Number: 1
• Product Code: MPW
• UDI-Device Identifier: 00613994239525
• UDI-Public: 00613994239525
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/12/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/30/2017
• Device Model Number: 7510050
• Device Catalogue Number: M705174B004
• Device Lot Number: M111806AAA
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: HUMIRA ¿ X 2 SHOOTS PER MONTH ; ADDERALL XR = 30MG X2 = 60MG ; AMLODIPINE - 10MG AM ; BENAZEPRIL - 10MG PM ; BUPROPION XL 150MG; CELECOXIB - 200MG ; CYANOCOBALAMIN - 1ML ; DULOXETINE DR - 60MG X 2 = 120MG ; EZETIMIBE 10MG ; FENOFIBRATE - 134MG ; HYDROCHLOROTHIAZIDE - 25MG ; LEUCOVORIN ¿ 5MG X 1 ; MAGNESIUM GLYCINATE ¿ 200MCG X 2 PM; MELATONIN ¿ 10MG X2 PM ; METFORMIN 500MG ; METHOTREXATE ¿ 2.5MG X 8 ; OMEPRAZOLEZOLE - 40MG ; PREGABALIN ¿ 100MG X 3 PER DAY; QUETIAPINE - 300MG ; ROPINIROLE - 1MG X 2 = 2MG ; ROPINIROLE ¿ 4MG ; TAMSULOSIN - 0.4MG ; VITAMIN D-3 ¿ 125MCG X1 AM
• Patient Outcome(s): Other; Disability; Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White