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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 Anemia (1706); Edema (1820); Erythema (1840); Fatigue (1849); Bone Fracture(s) (1870); Headache (1880); High Blood Pressure/ Hypertension (1908); Laceration(s) (1946); Muscle Spasm(s) (1966); Loss of Range of Motion (2032); Weakness (2145); Cramp(s) (2193); Myalgia (2238); Depression (2361); Joint Dislocation (2374); Numbness (2415); Neck Pain (2433); Neck Stiffness (2434); Shaking/Tremors (2515)
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
Per medical records, it was reported that on (b)(6) 2006: the patient underwent chest two views examination.Impression: no sign of acute pulmonary disease.No acute traumatic c hange detected in the chest.The patient underwent mri of the left shoulder without contrast.Impression: suspect a direct contusion injury to the left humeral head, soft findings raisings suspicious of injury of the inferior glenoid process and inferior adjacent labral cartilage such as would be seen with a bankhart type lesion, no sign of supraspinatus tendon injury or proximal biceps tendon injury.The patient underwent ct cervical spine without contrast.Impression: findings suspicious for no displaced fractures of the left inferior articulating facet of c6 and superior articulating facet of c7 as well as non-displaced fracture through the transverse process of c7 on the left associated very mild anterior subluxation of c6 upon c7, findings called to the emergency room staff upon completing of the patient's exam.On (b)(6) 2006: the patient underwent ct cervical spine without contrast.Impression: fracture of the left facet at c7 with no fragments in the spinal canal.On (b)(6) 2006: the patient presented with chief complaint of closed cervical.Fx w/o cord injury c6/c7 and underwent two view chest ex amination.Impression: no sign of acute pulmonary disease.On (b)(6) 2006: the patient presented with chief complaint of c spine and underwent cervical spine, one view.Impression: surgical instrument superimposes the soft tissues of the dorsal cervical region.The patient underwent cervical spine-crosstable lateral projection examination.Impression: localization image.The patient underwent cervical spine one view.Impression: intraoperative study.Surgical changes, lower cervical spine obscured by overlying soft tissues.Repeat radiography would be available if needed.On (b)(6)2006: the patient presented with pre-operative diagnosis of left c6 facet fracture with concurrent c6 subtle laminar fracture.There is delayed and progressive weakness in the arm along with radicular pain.This was not present initially but was has since come on in time.The patient underwent: open reduction internal fixation of a left c6-c7 facet and laminar fracture.This was done with halifax clamps and cable, left c6-c7 foraminotomy and c7-t1 foraminotomy, arthrodesis of c5-c6-c7, autogenous left iliac crest graft, allograft fusion with 5cc volume of osteofil allograft bone morphogenic protein, morsellized autogenous graft material for arthrodesis at c5, c6 and c7, open manual reduction of c6 on c7 fracture dislocation.Preop notes: the patient started out with an initial x-ray preoperatively and subsequent x-rays taken intraoperative to localize the specifies.The patient had removal of the bone fragments in proximity to the fractures c6-c7 facet.Bone graft which was subsequently then fashioned to fit in exactly in that area.The patient has then a reduction of the fracture itself, first with songer cable.With the crimping method utilized and realignment of the spinous processes with the titanium songer cable spanning from c5 spinous process to c7 spinous process.The surgeon went ahead and used one of the longer screws to connect it to hook portions.One hook portion was around the inferior margin of c7, the other around the superior margin of c5.The compression mode was instituted and this also realign the bone and keep it relatively still.Surgeon was able then to put a bone graft from his iliac crest, morsellized but sever bone graft directly in to the joint space which had benn decorticated and the rest of the bone on the lamina c5, c6 and c7 on the spinous processes as well.The neck was rigidly fixed.The area was hemostatic.Surgeon made a separate second incision in the left iliac crest dissected it down through the tube, principal muscle layers down to the iliac bone which was dissected anteriorly over the iliac bone and over the top of the iliac crest.Surgeon went ahead and used straight and curved osteotomes in combination to make a autogenous hip graft harvest and then surgeon morsellized that bone, the portion of which was used directly for a facet fusion but also morcellated it for different components posteriorly in the posterior cervical fusion aspect of it.Other implants used in the surgery were (clamp, screw).On (b)(6) 2006: the patient was discharged.The patient underwent single view chest examination.Impression: only minimal linear atelectatic change is noted within the left mid chest.No other significance abnormality is noted.On (b)(6) 2006: the patient with chief complaint of lt.6/c7.Impression: posterior fusion from c5 to c7 in good alignment.On (b)(6) 2006: the patient presented with muscle cramping and neck pain.The patient underwent cervical spine-seven views with flexion/extension including oblique views examination.Impression: essentially unchanged exam, posterior fusions from c5 to c7 which appears to be stable.On (b)(6) 2006: the patient presented with chief complains of neck pain and underwent ct cervical spine.Impression: findings raising the possibility of an unstable c6-7 posterior element fracture with anterior subluxation of c6 on c7 as described.This may account for the patient's clinical symptoms.The patient underwent ct thoracic spine.Impression: no specific thoracic spine radiographic abnormality is detected, anterior subluxation of ct on c7.These findings are described in detail on the dedicated ct cervical spine.On (b)(6) 2006: the patient presented with diagnosis of c7 radicular compression left side, cervical soft tissue edema, obesity, anemia, left glenoid fracture, left glenoid shoulder dislocation, and claustrophobia.The patient underwent surgical intervention of anterior cervical discectomy with bone graft, wherein medtronic plate and screws, fixation and fusion of c5-6 and c6-7 the patient underwent physical examination: neurological: examination proper shows the patient to be alert and oriented x three.The patient cranial nerves ii through xii individually tested as normal.The patient bulk is normal.The patient power shows weakness in his left shoulder more than right and is present in both.The patient has deltoid muscle impairment with the 3+/5 to 4-/5 weakness in his wrist flexor and extensors on the left and finger abductors and grip initially which have made substantial improvement.The patient underwent ecg.On (b)(6) 2006: the patient underwent cervical spine-one view lateral only.The patient presented with chief complaint of post of c5-6 and c6-7 cervical diskectomy and underwent cervical spine, ap and lateral views.Impression: postoperative changes of discectomy and fusion at c5-6 and c6-7.Laminectomy changes at c5, c6 and c7.The patient underwent cervical spine one view lateral only.On (b)(6) 2006: the patient underwent portable chest examination.Impression: poorly expanded lungs.Hypoventilatory change at the left lung base.On (b)(6) 2006: the patient was discharged.The patient underwent two view chest examination.Impression: linear atelectatic change at both lung bases.On (b)(6) 2006: the patient diagnosed with muscles cramps.The patient underwent cervical spine, 5 views with obliques.Impression: postop changes of cervical discectomy and fusion and fixation of the cervical spine from c5 to c7 as discussed, good alignment of the cervical vertebrae in ap, lateral and oblique projections.On (b)(6) 2006: the patient underwent cervical spine eight views including flexion and extension lateral views.Impression: anterior and posterior cervical fusion from c5 to c7 in good alignment with no abnormal movement.On (b)(6) 2007: the diagnosed with neck spasm and underwent radiology examination.Impression: mild multilevel degenerative disk disease but no evidence of acute fracture is noted.The patient presented with chief complains of neck spasm and neck fatigue and underwent cervical spine comp w/ flex <(>&<)> ext.Impression: anterior and posterior fusion from c5 to c7 with no abnormal movement.The patient presented with chief complaint of neck spasm and neck fatigue and underwent ct thoracic spine without contrast.Impression: post surgical change in the lower cervical spine with no new fracture noted.The patient underwent ct of the cervical spine without contrast.Impression: post-surgical changes from c5 to c7, grade i/ii c6-7 subluxation with post-surgical enlargement of the spinal canal, there appears to be small fracture of the left lamina at the c5 level.On (b)(6) 2008: the patient admitted with complaint of arm infection.The patient underwent physical examination.Impression: probably deep abscess, left arm, chronic pain.The patient underwent i<(>&<)>d of two deep left arm abscesses.On (b)(6) 2008: the patient presented with chief complaint of mcest pcp, f/u from car accident.Ros revealed: neurological symptoms: no convulsions, psychological symptoms: anxiety and depression has been to behav management: lawyer sent him there; states they told him 'you deserve to be angry and depressed, neurological system is unremarkable.The patient underwent physical examination.Neurological: system: non focal.Assessment: obesity, cervical spondylosis, headache, fatigue, depression, anxiety, pain disorder associated with psychological factors.On (b)(6) 2008: the patient was discharged.On (b)(6) 2009: the patient presented with chief complaint of mc med check.Patient underwent physical examination.Neurological: system nonfocal on (b)(6) 2009: the patient presented with chief complaint of mc, med check.Patient underwent physical examination.Neurological: system nonfocal: pt continues with tremors and weakness in upper extremities; wear neck collar.On (b)(6) 2009: the patient presented with chief complaint of mc med check/congestion.On (b)(6) 2009: the patient presented with chief complaint of lrl-med refills, brought radiology report want to lower pain med, pain scale 7.5.On (b)(6) 2009: the patient presented with chief complaint of tmg-meds.Patient underwent physical examination.Neurological: system nonfocal.On (b)(6) 2009: the patient presented with chief complaint of ar-med refill.Patient underwent physical examination.Neurological: system: nonfocal.On (b)(6) 2009, the patient presented with chief complaint of aw-f/u medication refills.The patient underwent physical examination.Neurological: system: non focal on (b)(6) 2009: the patient presented with chief complaint of fd-med check.On (b)(6) 2010: the patient presented with chief complaint of aw-pt for monthly medication.Neurological: system: non focal.On (b)(6) 2010: the patient presented with chief complaint of broken neck, chronic pain syndrome and cellulitis.Ros revealed: musculoskeletal: back pain, bone/joint symptoms, difficulty with adls, muscles weakness.Upper left extremities.Upper right extremities, myalgia, neck stiffness.The patient underwent physical examination: neurological: cranial nerves intact.No motor or sensory deficits, psychiatric: alert and orientated.No unusual anxiety or evidence of depression.On (b)(6) 2010: the patient presented with chief complaint of med refills.The patient underwent physical examination.Musculoskeletal: normal musculature, no joint deformities or abnormalities, normal range of motion for all four extremities for age.Neurological: cranial nerves intact.No motor or sensory deficits.Psychiatric: the patient is oriented to time, place, person, and situation.The patient's affect is normal.The patient is negative for anhedonia, is not anxious, does not exhibit compulsive behavior, behaves appropriately for age, has normal knowledge, has normal language, is not in denial, is not euphoric, is fearful, does not have flight of ideas, is not forgetful, does not have thoughts of grandiosity, denies hallucinations, feels hopeless, does not have increased activity, is not having memory loss, has no mood swings, has no obsessive thoughts, does not have paranoia, has normal insight, exhibits normal judgment, has normal attention span and concentration, does not have pressured speech, and has suicidal ideation.Comments: does deny suicidal thoughts, but has been depressed since disc hg from hos; wants to be able to support him.Has apt to see psychiatry in (b)(6) on (b)(6) ((b)(4)).We will communicate with them when this gets started.On (b)(6) 2010: the patient presented with chief complaint of monthly med refills and reaction to med.The patient underwent physical examination.Musculoskeletal: no skeletal tenderness or deformity.Cervical spine has muscle spasm, severe pain w/ motion lumbar spine has muscle spasm, severe pain w/ motion comments: l4 ix in 1994, no surgery but residual pain and shooting pain into left sciatic region.Neurological: cranial nerves intact.No motor or sensory deficits, psychiatric: alert and orientated.No unusual anxiety or evidence of depression.On (b)(6) 2010: the patient presented with chief complaint of med checks.Ros revealed neuro/psychiatric: positive for: focal weakness.Tremors.Onset: 3 years ago.Associated symptoms include shuffling gait, trouble arising from chair and gait disturbance.This is exacerbated by activity, anxiety and stress.It is relieved by rest and valium.Neurological: did not like the neurontin---stopped since it "made him feel drunk." neurological comments: did not like the neurontin---stopped since it "made him feel drunk." psychiatric comments: continues to see a psychologist in joplin.He has his girlfriend are back together and considering couples counseling.The patient underwent physical examination: musculoskeletal: normal musculature, no joint deformities or abnormalities, normal range of motion for all four extremities for age.Neurological: cranial nerves intact.No motor or sensory deficits, psychiatric: alert and orientated.No unusual anxiety or evidence of depression.On (b)(6) 2010: the patient presented with chief complaint of back pain.Patient underwent physical examination.Musculoskeletal: normal musculature, no joint deformities or abnormalities, normal range of motion for all four extremities for age, neurological: cranial nerves intact.No motor or sensory deficits, psychiatric: alert and orientated.No unusual anxiety or evidence of depression.On (b)(6) 2010: the patient presented with chief complaint of med refills.The patient underwent physical examination: musculoskeletal: normal musculature, no joint deformities or abnormalities, normal range of motion for all four extremities for age.Neurological: cranial nerves intact.No motor or sensory deficits.Psychiatric: alert and orientated.No unusual anxiety or evidence of depression.On (b)(6) 2010: the patient presented with chief complaint of back pain.The patient underwent physical examination: musculoskeletal: no skeletal tenderness or deformity.Cervical spine has muscle spasm, severe pain w/ motion comments: left arm and leg atrophy----strength 3+/5 vs 5+/5 on right.Psychiatric: alert and orientated.No unusual anxiety or evidence of depression.On (b)(6) 2010: the patient presented with pain and weight loss.The patient underwent physical examination.Musculoskeletal: normal musculature, no joint deformities or abnormalities, normal range of motion for all four extremities for age.Psychiatric: the patient is oriented to time, place, person, and situation.The patient's affect is normal.The patient is anxious, behaves appropriately for age, has normal knowledge, is fearful, does not have pressured speech, and does not have suicidal ideation.On (b)(6) 2010: the patient underwent colonoscopy.On (b)(6) 2011: the patient presented with chief complaint of pain.Patient underwent physical examination.Musculoskeletal: normal musculature, no joint deformities or abnormalities, normal range of motion for all four extremities for age.Neurological: cranial nerves intact.No motor or sensory deficits, psychiatric: alert and orientated.No unusual anxiety or evidence of depression.On (b)(6) 2011: the patient presented with chief complaint of pain.Ros revealed: neuro/psychiatric: focal weakness, gait disturbance, headache, incoordination, paresthesia, tremors.Musculoskeletal: back pain.The patient underwent physical examination: musculoskeletal: comments: marked left sided weakness.His gait is awkward with almost dragging left foot.Left upper extremity kept in flexion and adduction.Grip strength in left hand weak, with only third digit movement.Right side normal.Patient wears cervical collar due to neck injury and surgeries.On (b)(6) 2011: the patient presented with chief complaint of pain.On (b)(6) 2011: the patient underwent xr upr gi air contrast examination.Impression: no significant abnormality.On (b)(6) 2011: the patient presented with chief complaint of pain and test results.On (b)(6) 2011: the patient presented with chief complaint of pain and anxiety.On (b)(6) 2011: the patient presented with chief complaint of hypertension.The patient underwent physical examination.Neurological: level of consciousness: normal.Orientation: alert and oriented x 3.Grossly normal intellect.Memory: intact.Balance <(>&<)> gait: unsteady gait.Comments: pt has tremors all over his body.Psychiatric: alert and orientated.No unusual anxiety or evidence of depression.On (b)(6) 2011: the patient presented with chief complaint of med refills.On (b)(6) 2011, (b)(6) 2012: the patient presented with neck pain.On (b)(6) 2011: the patient presented with referrals.The patient underwent physical examination.Musculoskeletal: gait is unstable and limp.Neurological: level of consciousness: normal.Orientation: alert and oriented x 3.Grossly normal intellect.Memory: intact.Psychiatric: the patient is oriented to time, place, person, and situation.The patient demonstrates the appropriate mood and affect on (b)(6) 2012: the patient underwent lumbar spine, three view examination.Impression: degenerative disc disease in the lower lumbar spine including malalignment at l4-5 and that looks secondary to facet disease.The patient presented with neck pain.The patient underwent physical examination: musculoskeletal: comments: unable to abduct his left arm to greater than 45°.He has contracture of his left elbow approximately 80°.Grip strength 2/5 on the left and 5/5 on the right.Lower extremities with 5/5 strength on the right and 4/5 on the left.He has decreased flexion of his toes at 3/5 on the left.Reflexes equal and symmetric.On (b)(6) 2012: the patient presented with neck pain.Ros revealed: neuro/psychiatric: depressed mood, difficulty initiating sleep, marked diminished interest or pleasure.On (b)(6) 2012: the patient presented with chronic pain syndrome, hypertension, cervical repair, hemiplegia affecting nondominant side, cervical repair, depressive, closed fracture of cervical vertebra, therapeutic drug monitoring.On (b)(6) 2012: the patient presented with er f/u.The patient underwent physical examination.Musculoskeletal: comments: 1 cm laceration on the left shoulder without evidence of erythema.There is a scab in place.Tender to palpation.The patient presented with anxiety.On (b)(6) 2012: the patient presented with musculoskeletal pain.Ros revealed: neuro/psychiatric: difficulty initiating sleep, nocturnal awakening, numbness, tingling in the arms and legs.Musculoskeletal: decreased mobility, limping, weakness.The patient underwent physical examination: musculoskeletal: comments: patient is wearing a soft cervical collar.Psychiatric: the patient is oriented to time, place, person, and situation.The patient has normal insight, exhibits normal judgment, and does not have suicidal ideation.Comments: patient exhibits significant emotional distress.On (b)(6) 2012: the patient presented with musculoskeletal pain.The patient underwent physical examination: psychiatric: the patient is oriented to time, place, person, and situation.The patient has normal insight, exhibits normal judgment, the patient demonstrates the appropriate mood and affect.The patient presented with hypertension.On (b)(6) 2012: the patient presented with pain medication refill.Ros revealed: neuro/psychiatric; extremity weakness.The patient underwent physical examination: psychiatric: the patient is oriented to time, place, person, and situation.The patient demonstrates the appropriate mood and affect.The patient presented with depression.On (b)(6) 2012, (b)(6) 2013: the patient presented with anxiety and depression.On (b)(6) 2012: the patient presented with musculoskeletal pain and flu shot.The patient underwent physical examination: psychiatric: the patient is oriented to time, place, person, and situation.The patient has normal insight, exhibits normal judgment.On (b)(6) 2013: the patient presented with musculoskeletal pain.On (b)(6) 2013: the patient presented with med refills.Ros revealed: musculoskeletal: neck pain.The patient underwent physical examination.Musculoskeletal: gait is limp.Comments: pt wearing soft neck collar.Psychiatric: the patient is oriented to time, place, person, and situation.The patient has normal insight, exhibits normal judgment, the patient demonstrates the appropriate mood and affect.On (b)(6) 2013: the patient presented with chronic pain multiple and hemorrhoids.Ros revealed: neuro/psychiatric: negative for depressed mood and marked diminished interest or pleasure.The patient underwent physical examination: psychiatric: the patient is oriented to time, place, person, and situation.The patient demonstrates the appropriate mood and affect.The patient presented with headache.On (b)(6) 2013, (b)(6) 2014: the patient presented with medication refills.On (b)(6) 2013: the patient presented with chef complaint of hemorrhoids.The patient underwent physical examination: musculoskeletal: normal range of motion of neck, back and extremities.Normal muscle strength and tone.And tone neuro: cn 2-12 grossly intact, no focal or lateralizing deficits on (b)(6) 2013: the patient was admitted with pre-operative diagnosis of rectal bleeding and underwent colonoscopy to terminal ileum.On (b)(6) 2013: the patient presented with chronic pain management.
 
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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 Key5080169
MDR Text Key25911370
Report Number1030489-2015-02391
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
Type of Report Initial
Report Date 08/24/2015
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 08/24/2015
Initial Date FDA Received09/16/2015
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 Outcome(s) Other;
Patient Weight131
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