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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
Catalog Number 7510600
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Weakness (2145); Urinary Frequency (2275); Numbness (2415); Dysuria (2684)
Event Type  Injury  
Event Description
It was reported that from (b)(6) 2002 through (b)(6) 2003.The patient presented for physical therapy with one or more of the following: lower back pain, left leg symptoms, and back spasms.On (b)(6) 2002 the patient presented in er via ambulance with neck and low back pain following a mva.The patient underwent cervical spine x-rays which noted degenerative disc changes at c5-6 and c6-7.No evidence of acute fracture or dislocation.No evidence of prevertebral soft tissue swelling.Lumbar spine x-rays showed mild degenerative spurring is noted anteriorly at l3-4 and no evidence of acute fracture or dislocation.Medications prescribed: vicodin.On (b)(6) 2002: the patient presented with lower back pain radiating into the leg and foot, neck pain, pain between the shoulders, headache, and weak muscles.On (b)(6) 2002: the patient presented with severe headache and back spasms.On (b)(6) 2002: the patient reported spasms when they sneezed or coughed.On (b)(6) 2002: the patient presented with tingling in the left leg.On (b)(6) 2002: the patient presented with hip pain.On (b)(6) 2002: the patient presented with pain and underwent a lumbar spine mri which demonstrated grade i spondylolisthesis of l3 upon l4 that was degenerative in etiology.Hyper-intense t2 marrow signal within the pedicles and pars interarticularis bilaterally suggestive of a stress response and/or degenerative change.At l3-4 there was moderate intervertebral osteochondrosis/spondylosis and moderate ¿ severe degenerative facet joint disease bilaterally.There was a circumferential 2-3mm protrusion that narrowed the inferior dimension of the neuroforamen bilaterally.At l5-s1 there was a broad based posterior 3-4mm protrusion herniated nucleus pulposus with a focal hyperintense signal in the outer annulus in the right paracentral region.This emanated from a mildly dehydrated/degenerated intervertebral disc.There was mild degenerative facet joint disease bilaterally.On (b)(6) 2002: the patient presented with lower back pain.Per the encounter notes a mri of the lumbar spine had shown bulges at l3-4 and l5-s1.On (b)(6) 2002: the patient presented with lower back and leg pain.The patient reported having undergone physical therapy and utilizing a tens unit since the mva without relief.The patient had significant dysesthesia radiating from the sciatic notch in the buttocks to the posterior thigh down to the left foot in a l5-s1 dermatome pattern.The patient was extremely tender to palpitation over the l5-s1 paraspinal muscles, left > right.Medications: vicodin, neurontin 100mg, and skelaxin 400mg.On (b)(6) 2002: the patient presented with pain and underwent a lumbar spine mri which showed l5-s1 right partial laminectomy post-surgical changes; disc height loss and disc desiccation localized at l5-s1 with associated posterior annular fissure.Broad based posterior disc bulge at this level (4-5 mm) resulting in partial effacement of the lateral recesses a s well as moderate bilateral neuroforaminal encroachment; concentric disc bulge localized at l3-4 (3-4 mm) with associated bilateral facet hypertrophic change resulting in partial effacement of the lateral recesses as well as moderate bilateral neuroforaminal encroachment; no abnormal signal or enhancement within the conus or within the thecal sac.On (b)(6) 2002: the patient presented with pain in the low back, left buttocks and down to the left calf with some numbness in foot.Diagnosis: lumbar strain and lumbar disc syndrome.On (b)(6) 2002: the patient underwent a caudal epidural injection.No patient complications were noted.On (b)(6) 2002: the patient presented with back and left leg pain.It was reported that the patient had had an epidural injection approx.Ten days prior with good relief.On(b)(6) 2002: the patient presented with back pain, paresthesias bilateral legs, and lumbar disc disease.The patient underwent a lumbar epidural injection, l4-5.No patient complications were reported.On (b)(6) 2002: in a telephone encounter the patient reported improvement to pain after the injection.On (b)(6) 2002: in a telephone encounter the patient complained of neck pain, headaches, mid back pain and low back pain into he left leg.On (b)(6) 2002: it was noted that the patient had cervical and lumbar pain and weakness.On (b)(6) 2002: the patient presented with mild urinary urgency, continued back pain, left sciatic pain and a sense of weakness in the left leg.It was noted that there was some indications of recurrent stenosis.On (b)(6) 2002: the patient underwent an emg which revealed no abnormalities.On (b)(6) 2002: reportedly the patient underwent a ct myelogram which showed stenosis at l3-l4; moderate 4 mm disc bulge, moderately effacing the thecal sac and moderately narrowing both of the lateral recesses at l3-l4; ls-s1, moderate 4 mm broad posterior recurrent disc protrusion, slightly greater towards the right, mildly impinging on the thecal sac and anterior surface of both s1 sheaths; severe degenerative hypertrophy involving the right s1 joint; and a previous partial right-sided laminectomy at l5-s1.On (b)(6) 2002: the patient presented with sharp pain in back when in a uppermost sitting position and leg and hip pain with prolong standing, left > right.The patient also reported some right groin pain.On (b)(6) 2002: the patient presented with herniated nucleus pulposus l5-s1 and l3-l4; instability with anterolisthesis l3 on l4; spinal stenosis l3-4 and l5-s1; and possible diskogenic pain l5-s1 and l3-l4.Medications: hydrocodone, neurontin, cyclobenzaprine.New: bextra.On (b)(6) 2002: the patient underwent a discogram.The myelogram revealed a non-concordant 4 out of 10 pain at l3-4, normal disc at l4-5 and a concordant, although lesser severe pain, at l5-s1.The patient continued to have a ¿catching¿ in his back, low back and lower extremity pain (b)(6) 2002: the patient presented with back and pain in both legs.Diagnosis: lumbar disc syndrome.On (b)(6) 2003: the patient presented with pain in lower back with sciatic pattern on the left side and a right lateral hip and groin pain.On (b)(6) 2003: the patient presented with the preoperative diagnosis of l5-s1 recurrent disk herniation with disk disruption and l3-4 spinal stenosis and spondylolisthesis.The patient underwent surgery which consisted of a l5-s 1 re-do laminectomy; l3-4 laminectomy; l3-4 bilateral posterolateral intertransverse process fusion; l5-s 1 bilateral posterolateral intertransverse process fusion; non-segmental pedicle screw instrumentation, ls-s1, bilateral; harvest of bone graft from the right posterior iliac crest; and elective physiological nerve root and pedicle screw testing.It should be noted, per the operative report: ¿the spinal canal was entered underneath the l5 lamina by teasing the ligamentum flavum and scar away from the bone.There was dense adherent scar that was worked through on the right side.Unfortunately, a tear in the dura did occur on the dorsal aspect that was easily repairable with a running locking nylon suture, and towards the end of the procedure, this area was covered with fibrin glue and then a fat pad.After development of the laminectomy and removal of partial facetectomy on both sides, there was adequate space for the nerve roots.I had intended to do an inner body fusion, but the scar was so densely adherent that i did not feel like i could safely accomplish this procedure, and elected to go just with the posterolateral fusion¿ it was elected not to place instrumentation at l3-4 so as not to create undue stress on the l4-5 facet joints.Instead, the lateral recesses were prepared for fusion at l3-4 and l5-s 1 on both sides¿.No patient complications were noted.The patient lost an estimated 675 cc in blood.(b)(4) system instrumentation.On (b)(6) 2003: the patient was discharged from hospital.Per the discharge summary diagnosis: the patient presented with the diagnosis of anxiety, herniated intervertebral disc, gerd, adverse drug reaction (puritis with morphine) and fever.A pe had been suspected initially but then ruled out after d-dimer tests and a normal ct angiogram.It was recorded that the elevated temperature or anxiety was most likely related to the steroids and pain.Medications: lortab, skelaxin, and ultram.On (b)(6) 2003: the patient presented with low back, bilateral leg pain, slight headache, and some drainage from the surgical wound.Staples were removed.On (b)(6) 2003: initially in a telephone encounter, the patient reported significant headache, 101 degree fever, and significant drainage over 24 hours.The patient was admitted to hospital.On (b)(6) 2003: the patient presented with post operative deep wound infection and underwent surgery that consisted of drainage and debridement.Wound cultures were conducted.Per the operative report ¿¿the fascial layer was inspected and was intact except for the very top portion, approximately 2 cm from which some purulent material could be expressed.The fascia was then opened, and there was purulence, especially in the lateral gutters along the instrumentation infusion site.After opening up the layers, the area of previous decompression was inspected, and the early scar: tissue was cleared from off the dura.There was no evidence of any leakage of cerebral spinal fluid around the previous repair.¿¿ no patient complications were reported.Cultures revealed staphylococcus aureus.On (b)(6) 2003: in a consultation report ¿the infection has approached but does not appear to involve the rod.Await identification of bacteria and sensitivity testing.Continue vancomycin at the current dose.Would add cefepime 2 grams iv q i2h pending the final culture results.Given the depth of the infection, anticipate six weeks iv antibiotics, therefore place central access for home iv antibiotic therapy¿¿ on (b)(6) 2003: the patient presented with minimal symptoms in lower back and legs.Per the encounter notes the patient was undergoing outpatient iv antibiotic treatment for a deep wound infection with methicillin sensitive staph aureus.X-rays of the lumbar spine showed bone graft and hardware in good position.On(b)(6) 2003: the patient presented with low back and left hip pain and wound drainage.The patient continued to have a central line for antibiotic therapy, the patient reported feeling improved.There was some discoloration around the incision site which was thought to probably be a resolving hematoma.On (b)(6) 2003: the patient presented with minimal swelling at the wound site and slight subcutaneous fluid.Per the encounter notes the patient had called the physician the night before and reported a fever and increasing pattern of back and left leg pain.The patient had been on antibiotics for 10 days at this point.Diagnosis: post operative back wound infection.On (b)(6) 2003: the patient presented with some aching pain in back and mild groin pain.Medications: lortab.On (b)(6) 2003: the patient presented with some low back and left leg pain with dysesthesia present in the left lower extremity.The wound infection was noted as resolved.The patient was to start physical therapy.On (b)(6) 2003: the patient presented with the diagnosis of displacement intervertebral lumbar disc.On (b)(6) 2003: the patient presented with stiffness and soreness in the back and some left lateral hip and groin pain.X-rays revealed plenty of bony graft at l3-4 and no motion at that level.The pedicle screws at l5-s1 were in good alignment with possible lucency at the s1 screw on the left.The fusion at that level was not as generous in proportion as the other level.Medications: flexeril and lortab.On (b)(6) 2003: in a telephone encounter, the patient reported missing two days of physical therapy due to increased pain in the left groin and left leg.Per the nurse¿s notes, x-rays had revealed that there was delayed fusion on the left along with lucency around the s1 bone screw.On (b)(6) 2003: in a telephone encounter, the patient reported significant pain in back and leg; extreme discomfort, and was now using a walker for ambulation.On (b)(6) 2003: the patient presented with anorexia, fevers, chills, night sweats, and pain.The patient underwent surgery for a decompressing of abscessing in the left side of the hardware.At that time the hardware was found to be loose but the equipment was not available to remove it.On (b)(6) 2003: the patient presented with the need for long term antibiotic treatment and underwent a picc line placement.No complications were reported.On (b)(6) 2003: the patient was discharged from hospital.On (b)(6) 2003: the patient presented with continuing pain and a ¿catch like phenomenon similar to a possible instability.¿ the patient was still having drainage from the wound.The patient was admitted to hospital.On (b)(6) 2003: the patient presented with the preoperative diagnosis of wound drainage status post-surgery, retained hardware l5-s1, lumbar abscess, and epidural abscess.Per the operative report: ¿¿the hardware was removed and pus was found on the right pedicle screw area.These were both removed and sent to pathology.Cultures were taken to pathology.Further decompression was performed at that level as well as decompressing the nerve roots and evaluation of epidural space.No pus was found in this area¿¿ no patient complications were reported.On (b)(6) 2003: the patient was discharged from hospital.On (b)(6) 2003: the patient presented with the diagnosis of lumbar disc disruption, status post fusion, status post infection and recent debridement and removal of hardware.Per the encounter notes the patient returned after a recent hospitalization for recurrent infection.The patient had a picc line for antibiotic therapy and was feeling significant improvement.On (b)(6) 2003: the patient presented post op, for suture removal.The incision was almost completely healed with the exception of on small area in the middle.Labs were drawn which revealed c-reactive protein at 2.00.On (b)(6) 2003: per the encounter notes the patient¿s culture had shown (b)(6) organisms and was being treated with clindamycin.The patient had ¿¿ temporarily suspended his iv antibiotics following his last dose two nights ago, because of tongue sensitivity.The patient recalled that during a previous course of zosyn therapy earlier this year, he developed significant glossitis and skin desquamation involving the mucosal surfaces of his mouth and lips.He is having no desquamation at this point and has complaints confined to a geographic appearance to his tongue and some hypersensitivity on the dorsal aspect of his tongue¿¿ the patient was to resume the antibiotic.On (b)(6) 2003: the patient was continuing with iv antibiotics.The patient was feeling significant improvement with mild soreness in his back and minimal leg symptoms.The patient did not require any pain medications at this time.On (b)(6) 2003: the patient presented with mild discomfort.The patient was on a six week course of oral antibiotics for the treatment of a lumbar spine infection.Lumbar spine x-rays showed no movement at the two levels of fusion (l3-4 and l5-s1).Labs showed sedimentation rate, crp and white count normal.The wound appeared benign.On (b)(6) 2003: the patient underwent a lumbar spine mri which showed abnormal endplate changes centered edema involving the l5 and s1 vertebral bodies as well as enhancement within disc consistent with discitis and osteomyelitis.The degree of narrow edema was diminished with improvement from the prior study but remained abnormal.The posterior paraspinous collection had resolved.There was diminishment of the abnormal material in the epidural space at l5-s1 consistent with phlegmon and/ or possible abscess but this too showed improvement.There was still deformity of the thecal sac.On (b)(6) 2003: the patient presented with lower back and left leg pain and restricted rom secondary to discomfort.Medications: vicodin skelaxin, and flexeril.On (b)(6) 2003: the patient presented with a ¿complicated history.Per the encounter notes a recent mri showed some concern for osteomyelitis and discitis as well as increased scar and possible return of the abscess.The patient was asymptomatic without radiculopathy or pain.The patient did have some swelling in the back.Impression: possible osteomyelitis at l5-s1 vertebral bodies.On(b)(6) 2003: the patient reported they were doing very well but still had some achiness in the low back.X-rays showed good bone bridging posteriorly.There may have been a fracture of the pars at that level.At l5-s1 there appeared to be calcification of the disc and there appeared to be an autofusion at the l5-s1 level.It was noted that this may have been due to the inflammatory discitis which was probably causing increased fusion at that level.On (b)(6) 2004: the patient presented with infections discitis and abscess posteriorly.On (b)(6) 2004: the patient presented with low back pain described as a ¿heaviness¿ and left leg pain.Per the encounter notes the patient had been on long term antibiotics and continued on clindamycin.Diagnosis: grade i spondylolisthesis and slight kyphosis at l3-l4 with probable intact lateral mass fusion; significant disc resorption at l5-s1 and question of a spontaneous partial fusion; and chronic inflammatory phlegmon l4-s1.On(b)(6) 2004: the patient for a preoperative evaluation.The patient had been placed on ensure to ensure adequate nutrition.Chest x-rays were taken which were normal.On (b)(6) 2004: the patient presented with the preoperative diagnosis of spinal instability at l3-4; grade 1 spondylolisthesis l3-4; spinal stenosis with radiculopathy, and internal disc disruption l3-4, l4-5, and l5-s1.The patient underwent surgery which consisted of a total laminectomy at l4 and l5 bilaterally; bilateral foraminotomies at l3-4 and l5-s1; resection of extreme amount of epidural fibrosis; posterolateral interbody fusion on the left l5-s1; transverse process fusion l3 to l5 on the left; neuro-monitoring of the nerve roots; and bone marrow aspirate from the left posterior iliac crest.Per the operative report ¿ ¿revealed solid bone across the interspace at 5-1 therefore we did not break through this area.We repositioned up to 4-5 and did total diskectomy with interbody fusions, interbody fixations with danek cages at both the 3-4 and 4-5 levels.This was filled with bmp in a sponge and in front of the device with connexus¿¿ on (b)(6) 2004: the patient was discharged rom hospital.On (b)(6) 2004: the patient presented for abdominal skin staple removal with a small disruption in the middle portion of the patients incision.On (b)(6) 2004: the patient presented, approx.One month post op, with improved back pain and intermittent improved left leg pain.The patient was wearing an abdominal binder and utilizing a pulsed electromagnetic field (pemf) device.The patient reported that after using the device for 20 minutes it gave them a headache which resolved when the device was removed.X-rays showed good instrumentation placement and intact fusion masses.The patient was to start physical therapy.On (b)(6) 2004: it was reported that the patient had been doing ¿quite well¿ up until a week or so prior when they developed a bad cold there was a lot of sneezing and coughing which aggravated the symptoms in the patient¿s back.The patient had received antibiotics and at the time of the encounter the cold symptoms seemed resolved however the patient was still having residual increased pain.They also reported intermittent shooting pain posterolaterally down the thigh to right below the knee.The patient had been ¿using some type of e-stim¿ at home which had been helpful.X-rays showed good cage placement and excellent amount of bone in the lateral gutters l3-4 bilaterally and down to l5, possibly even to s1 on the left side.On (b)(6) 2004: the patient presented with intermittent left leg symptoms.04 oct 2004: the patient presented with back pain.The patient also reported that occasionally when they walked, the left side of their back ¿pops¿.This was at the l2-l3 level.The patient¿s impairment rating was at 25%.X-rays showed device intact with bridging and bone growth through the devices at all three levels.On (b)(6) 2005: the patient presented with ¿deep soreness in the lumbar spine and bilateral groin pain with intermittent numbness to the feet.Per the encounter notes the patient ¿appears to have stalled¿.The patient was seeing psychiatrist and was undergoing biofeedback.On (b)(6) 2005: the patient presented with aches and pains throughout his truck and leg, soreness and tenderness in the low back and pain extending to groin and testicles.The patient also reported generalized weakness and limited tolerance to activity.Diagnosis: post laminectomy syndrome of the lumbar spine.Per the encounter notes ¿his complex history and extended time being inactive due to his condition have resulted in significant deconditioning and loss of function.¿ an oswestry placed the patient in the moderate category.On (b)(6) 2005: the patient presented with lumbago and post laminectomy syndrome.The patient reported one or more of the following: pain in left buttock, bilateral groin pain, poor lower extremity strength and endurance, and back pain and poor mobility.On (b)(6) 2009: the patient presented with low back pain.On (b)(6) 2009: the patient presented with joint pain and tenderness with intermittent swelling and morning stiffness in the left elbow.Medications: hydrocodone-acetaminophen, prevastin, cialis.On (b)(6) 2009: the patient presented with back pain, joint pain and tenderness.The patient reported diminished ability to perform activities daily living.On (b)(6) 2009: the patient presented with ear left ear pain.The patient had a history of sinusitis.Impression: cervical sprain/strain.Neck pain.On (b)(6) 2009: in a telephone encounter the patient reported blood in urine.On (b)(6) 2010: the patient presented for an evaluation of hematuria ¿ condition existed one week.The patient was experiencing severe dysuria with gross hematuria etiology unknown.On (b)(6) 2010: the patient presented with back and left shoulder pain.The patient was experiencing joint pain and tenderness and pain with movement.Previous diagnosis was listed as: effusion of the lower leg joint, hyperlipidemia, psychosexual dysfunction with inhibited sexual excitement, pain in join involving shoulder region, sickle cell disease without crisis, backache, anemia, lumbago.Gross hematuria to be determined.Medications: hydrocodone-acetaminophen, tramadol, cialis, hydrocortisone/neomycin/polymyxin, levitra, pravastin.On (b)(6) 2010: the patient presented with the diagnosis of: sickle cell trait, back pain, rotator cuff syndrome, and hyperlipidemia.The patient complained of left shoulder and back pain.Medications: soma, cialis, hydrocodone-acetaminophen, cialis.On (b)(6) 2010: the patient underwent labs which revealed high rdw and cholesterol.On (b)(6) 2010: the patient presented with right shoulder pain radiating into the right arm.The patient also complained of back and joint pain.On (b)(6) 2011: the patient presented with right shoulder, joint, and back pain.The patient described the shoulder pain as tingling.The patient underwent labs which revealed high creatinine and cholesterol and low egfr (kidney screen) and vit d levels.The patient was started on vit d.On (b)(6) 2011: the patient presented with cramping in hands, legs, and the abdominal region.The patient also reported back pain, joint pain, and joint swelling.Diagnosis: hyperlipidemia, back pain, sickle cell trait, rotator cuff syndrome, renal insufficiency, joint effusion right knee, and muscle cramps.Labs were run which revealed high creatinine and low egfr levels.On (b)(6) 2011: the patient presented with sickle cell and back pain.The patient underwent labs which revealed high creatinine and cholesterol levels.On (b)(6) 2012: the patient presented with back pain.Diagnosis: renal insufficiency, hyperlipidemia, back pain and sickle cell trait.Labs were run which revealed high cholesterol and a vit d deficiency.On (b)(6) 2012: the patient presented with a history of large colonic mass x2.Per the encounter notes each time it has been benign but the gi doctor was concerned about the nature of the current lesion and suggested its removal.Diagnosis: colonic polyps, sickle cell trait, back pain, renal insufficiency, and hyperlipidemia.On (b)(6) 2012: the patient presented with cold symptoms onset 1-2 weeks prior.The patient also complained of back pain.On (b)(6) 2012: the patient underwent labs which revealed high glucose levels.On (b)(6) 2012: the patient presented with the diagnosis of knee, back, abdominal pain and hyperlipidemia.The patient was also having his allergies evaluated.On (b)(6) 2013: the patient presented with cold and urinary tract infection symptoms including nasal congestion, chest congestion, coughing and runny nose.On (b)(6) 2013: the patient presented with back pain.
 
Manufacturer Narrative
(b)(6).(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.
 
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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
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key4237576
MDR Text Key4997274
Report Number1030489-2014-04279
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 10/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7510600
Device Lot NumberM111003AE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/09/2014
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 Number1
Patient Outcome(s) Required Intervention;
Patient Weight86
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