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U.S. Department of Health and Human Services

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

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Hearing Impairment (1881); Hearing Loss (1882); Hepatitis (1897); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Loss of Range of Motion (2032); Halo (2227); Neck Pain (2433); Ambulation Difficulties (2544)
Event Type  Injury  
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.
 
Event Description
It was reported that on (b)(6) 2007 the patient was admitted.He was diagnosed with paravertebral cervical abscess.Epidural abscess status post drain age.Left vertebral artery mycolic aneurysm status post coiling and stent placement.Odontoid osteomyelitis.Altered mental status.Right ear polymicrobial infection.Hypertension.He underwent the following procedures: the patient l1ad a transthoracic echocardiogram performed on (b)(6) 2007, this showed a left ventricular ejection fraction of 60%-65%.There was no definitive evidence for endocarditis.The patient had ekgs performed on (b)(6) 2007 and (b)(6) 2001 with no evidence for st elevations or findings consistent with infarction or ischemia.The patient had a left subclavian central line placed on (b)(6) 2007 that was removed on (b)(6) 2007.The patient had a ct head and neck performed an (b)(6) 2007.The patient had an mra circle of willis on (b)(6) 2007.The patient had an mri of orbits and face and neck on (b)(6) 2007.The patient had an mri neck with and without contrast on (b)(6) 2007.The patient had an abdominal kub on (b)(6) 2007.The patient had multiple chest x-rays performed on (b)(6) 2007.The patient had a ct of his head with and without contrast on (b)(6) 2007.The patient had an arteriogram 4-vessel in the head on (b)(6) 2007.The patient had mibi performed on (b)(6) 2007.The patient l1ad coiling and stent placement on (b)(6) 2007.The patient had vertebral arteriogram on (b)(6) 2007, which showed evidence for recanalization at1d slight growth of the aneurysm compared to prior.The patient had modified barium swallow performed on (b)(6) 2007 with a repeat on (b)(6) 2007, which showed no evidence for aspiration risk.The patient had a cervical spine pa and lateral on (b)(6) 2007, this showed stable cervical vertebra.The patient had cta head and neck performed on (b)(6) 2007 used as a baseline study for followup evaluation in one month a time.On (b)(6) 2007, the patient was diagnosed with ventilator dependence with respiratory insufficiency and c-spine precautions.Tracheostomy was planned.No complications.On (b)(6) 2007, the patient presented for a follow up visit due to cervical osteomyelitis and vertebral pseudoaneurysm.He was diagnosed with a cervical osteomyelitis as well as failure to wean and vertebral pseudoaneurysrn.He was treated with coil embolization for vertebral pseudoaneurysrn.He was also tracked on this admission, and he was treated in a collar for his cervical spine.At this point, he presents today with persistent neck pain.He has undergone a ct of the neck for evaluation of his vertebral pseudoaneurysm.He has also had plain films of his cervical spine obtained.The patient presented to the clinic and stated that he was in significant pain in regard to the right side of the neck, right shoulder and upper arm, which was new since his discharge.Imaging: the patient had a cervical spine series, the report describing progressive erosion of odontoid, atlantoaxial malalignment and predental widening.On (b)(6) 2007, the patient was admitted for surgery.The neurosurgery took place on (b)(6) 2007.The patient underwent the following procedures: posterior c1-2 arthrodesis, posterior c1-2 instrumentation, iliac crest autograft.An incomplete c1 arch was found.Post-op diagnosis was c1-2 instability.Mri of the cervical spine demonstrating an inflammatory soft tissue mass anterior to the spine.No drainable fluid collections identified.Erosion of the odontoid with widening of the atlanto-odontoid interval and questionable integrity of the transverse ligament.On (b)(6) 2007, the patient was admitted due to cervical instability.On (b)(6) 2007, upright ap, lateral, and supine views of the cervical spine demonstrating soft tissue fullness of tl-t2.On (b)(6) 2007, posterior cl-c2 arthrodesis, posterior cl-c2 instrumentation, iliac crest autograft, placement of halo.He was discharged on (b)(6) 2007.The patient originally developed a paravertebral abscess after steroid injections into his neck which was drained by ent and shown to be mssa.Patient then developed odontoid osteomyelitis and a mycotic pseudoaneurysm of his left vertebral artery.The pseuodoaneurysm was coiled and stented by vir and the osteo was treated by a tong course of iv abx, followed by continuous po abx.Patient was eventually discharged to rehab, and he followed up in the neurosurgery clinic, with increased neck pain.The patient had a ct scan which showed worsening osteomylitis on (b)(6) 2007, the patient presented for an office visit.Per op notes his imaging demonstrates that there is significant motion at cl-2 and that when he is in a supine position on the ct scan, he reduces to a point where the lateral masses of cl and c2 overly one another anatomically.The patient has instability at c1-2.The patient was recommended the use of bmp.On (b)(6) 2007, the patient presented with c1-c2 instability.He underwent the following procedures: posterior cl-c2 arthrodesis.Posterior c1-c2 instrumentation.Iliac crest autograft.Placement of halo.The bone graft was fashioned to fit within the gap between c1 and c2 but, again, we could not use sublaminar cables due to the c1 arch defects.The high-speed drill was then used to decorticate the inferior laminar edge of c1 and the superior laminar edge of c2.A rod was placed into the heads of the right-sided polyaxial screws and setscrews were then used to tighten this down using standard technique.Once this construct was in place, the bone graft was wedged between the cl and c2 posterior elements and, again 1 no cable could be used due to the cl arch defect.Bmp sponges were prepared using standard recommendations and then were placed over the bone graft being careful not to enter these into the spinal canal.Operative findings: incomplete c1 arch.No complications were reported.On (b)(6) 2007, the patient was admitted due to halo prob and neck pain and was discharged the same day.On (b)(6) 2007, the patient presented for a status update post tracheostomy tube placement.He initially presented for dysarthria and gait instability.On (b)(6) 2007, the patient presented for an office visit due to neck spasm and pain.On (b)(6) 2007, the patient was admitted due to halo pain.He was discharged on (b)(6) 2007.On (b)(6) 2007, the patient presented with neck pain and ear pain.On (b)(6) 2007, the patient presented for an office visit to follow up on his c1-c2 fusion.No complications were reported.On (b)(6) 2007, the patient presented with continued head pain.Assessment: depression,hypertension, serous otitis media, mycotic ane urysm status post stenting.On (b)(6) 2007, the patient presented for an office visit to follow up on bilateral otorrhea.The patient had been complaining bitterly of the halo and reached a point when he decided to remove his own halo.Impression : hypertension, narcotic pain medication abuse.On (b)(6) 2007, (b)(6) 2008, the patient presented for bp check and complaint of continued neck pain.Assessment: hypertension, difficulty sleeping/anxiety, pain.On (b)(6) 2009, (b)(6) 2008, the patient presented for an office visit for follow-up chronic otitis media and ear pain.He underwent mastoid bowl cleaning simple bilaterally using a microscope.Test results: the patient had type b tympanograms bilaterally.Impression: acute otitis media bilaterally.The hcp gave the patient a prescription for a 14-day course of avelox to clear the otitis media.Chronic ear disease status post bilateral canal wall down rnastoidectorny.Hcp stressed to the patient the need for regular mastoid bowl cleaning.On (b)(6) 2009, the patient presented for an office visit for his bilateral chronic ears.He has had bilateral cavities with a right-sided tympanoplasty and left-sided small meatoplasty which really further complicates ear cleaning.He was recommended a meatoplasty on the left ear last year, but has not followed.He also has had maximum conductive hearing loss bilaterally, which was confirmed with audiometric evaluation.Also, ear cleaning was performed and the patient was instructed that ossiculoplasty might help.On (b)(6) 2010, the patient presented with left cholesteatoma, chronic bilateral mastoiditis, status post bilateral canal wall down m astoidectomy, eustachian tube dysfunction.He underwent left revision tympanoplasty with middle ear exploration, left meatoplasty, left intraoperative neurophysiologic testing x2 hours of cranial nerve vii and use of operating microscope x2 hours.No complications.On (b)(6) 2010, the patient presented for an office visit.He has a history significant for bilateral tympanomastoid surgery with the prosthesis placed in the right ear.He complained of draining from the ears, the left being worse than the right.The left has been smelly, grayish white discharge, while the right ear has drained blood intermittently.Per op notes he had a ct scan performed, which showed some concerns in the left ear for possible cholesteatoma and increased mastoid fluid and air.Assessment: conductive hearing loss with otorrhea and possible cholesteatoma.On (b)(6) 2010, (b)(6) 2011, (b)(6) 2012, the patient presented for an office visit for follow ups for for his bilateral chronic ear issues.On 16 feb 2011 the patient presented with chronic ears and his bilateral tyrnpanomastoid cavities.His assessment was bilateral cavities with poor hearing.On (b)(6) 2011, the patient presented with conductive hearing loss.He was implanted left osseointegrated implant baha.On (b)(6) 2012, the patient presented with a tracheocutaneous fistula and htn, hld and history of cva scheduled for closure of his tracheocutanous fistula.Per op notes the patient underwent an ecg.On (b)(6) 2012, the patient presented with tracheocutaneous fistula.He underwent closure of tracheocutaneous fistula.No complications.Operative findings: evidence of a 1 cm tracheocutaneous fistula.Closed with imbrication of the fistulous tract and closed using a triple two-layer closure.On (b)(6) 2012, the patient was admitted due to dyspnea.On (b)(6) 2012, the patient was discharged.On (b)(6) 2012, the patient presented for an office visit.The patient did have a complication of subcutaneous air.On (b)(6) 2013, the patient presented with cerumen impaction.He underwent mastoid bowl cleaning, bilaterally.The findings were as f ollows: at the level of the mastoid bowl, a dense amount of cerumen had been appreciated during our exam.It was unable to be cleaned.So we turned our attention towards the mastoid bowl debridement.Using a combination of suction alligator forceps, we were able to remove all the remaining debris and epithelial sloughing without difficulty until underlying healthy mucosa was seen.This was then performed on the contralateral side in the same fashion and again, in the posterior-superior aspect, we were able to remove all the debris until it was completely cleared.The patient tolerated this procedure well without difficulty.The following assessment were made : history of chronic otitis media in the setting of bilateral canal wall down mastoidectomies.Hearing loss with a baha placed on the left.History tracheocutaneous fistula, now status post closure.On (b)(6) 2013, the patient presented with a complaint of (b)(6).The patient was diagnosed with (b)(6) in approximately 2001 while he was incarcerated.He has had a number of chronic medical conditions.He complained of loss of appetite and chronic headaches.Impression: asymptomatic (b)(6).He is a man with multiple comorbid medical conditions including ongoing alcohol use.(b)(6).At this point, the patient appears to have mild liver disease based upon his laboratory studies that indicate intact (b)(6)synthetic function.We will check the fibrosure test, but with his platelet count it is unlikely that he has significant fibrosis.However, he certainly does have risk factors for advanced liver disease with continued alcohol abuse in the setting of (b)(6).I have counseled him about the importance of discontinuing all alcohol intake.We will defer potential treatment for (b)(6) until newer therapies are available with a better side effect profile.Iron deficiency anemia.The pa tient states that he is scheduled for a colonoscopy by his primary physician sometime next month.Follow up will be with his primary physician.(b)(6) ultrasound will be scheduled at the time of his next visit, which will be in approximately october.(b)(6) a vaccine #1 was administered at this clinic visit.On (b)(6) 2013, the patient presented for a follow up appointment.His assessment was: doing well with bilateral canal wall down tympanomastoidectomy.Doing well with left-sided baha.Mixed hearing losses.On (b)(6) 2013, the patient presented with neck pain and lower back pain.Review of systems: review of 12 systems is pertinent, positives for arthritis, chest pain, depression, difficulty walking, easy bleeding, easy bruising, headaches, shortness of breath, stomach pain, unintentional change in his weight and hearing loss.Musculoskeletal: reveals limited range of motion of the cervical spine.He has normal range of motion of the lumbar spine.There is a healed midline incision in the posterior cervical spine consistent with his previous c1-c2 fusion.His strength examination is full at 5/5 in his upper and lower extremities.Neurologic: he has intact sensation to light touch in the upper and lower extremities.His reflexes are 2+ and symmetric throughout.He has downgoing toes, negative clonus, negative hoffmann's and negative spurling's maneuver and negative lhermitte's and negative faber's maneuver bilaterally.His gait is within normal limits.
 
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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
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5049298
MDR Text Key24881786
Report Number1030489-2015-02178
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Report Date 08/03/2015
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 Not provided
Initial Date FDA Received09/02/2015
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 Number1
Patient Weight83
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