• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number 7510800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Diarrhea (1811); Headache (1880); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Weakness (2145); Burning Sensation (2146); Stenosis (2263); Ulcer (2274); Injury (2348); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
Event Type  Injury  
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.
 
Event Description
Per medical records, it was reported that (b)(6) 2003: patient presented with chief complaint of pain and swelling of great toe.He had cellulitis of toe, ulceration of bottom of toe.He had significant pain and redness of toe.Review of systems reveals that patient has chronic nausea, numbness of left upper extremity and pain from his neuropathy.Assessment: cellulitis and toe ulceration, hypertension, neuropathy with secondary chronic pain syndrome.Patient was admitted to hospital.(b)(6) 2003: patient presented with pre-op diagnosis of paronychia and ulcer of the right great toe and underwent removal of right great toe nail and debridement of right great toe ulcer.(b)(6) 2003: patient underwent insertion of pic/picc catheter.Some difficulty was reported.(b)(6) 2003:patient presented with pre-op diagnosis of need for long term iv access for antibiotics and underwent insertion of groshong catheter.(b)(6) 2003: patient was discharged from hospital.Per discharge summary, patient underwent debridement of great toe, insertion of groshong catheter and bone scan procedures during the course of admission.Discharge diagnosis: cellulitis/osteomyelitis of the right great toe and neuropathy.(b)(6) 2003: patient underwent removal of groshong catheter.(b)(6) 2004:patient presented with increased right foot pain with some drainage.Patient has nausea and diarrhea secondary to his dumping syndrome.Patient is complaining of increased swelling, redness and pain of the right foot and toe.Physical examination of extremities reveals right foot has a thick callous of great toe and there is some necrotic tissue along the nail bed of right great toe.There is some erythema and warmth of right great toe.Patient was admitted to hospital for possible osteomyelitis and gout flare.(b)(6) 2004: patient was discharged from hospital.Discharge diagnosis: gout, gerd ,htn, parkinson, foot ulcers secondary to pressure.(b)(6) 2004:patient underwent mri of head w/wo contrast.Diagnosis: tremor.Impression: ethmoid and frontal sinusitis.No acute intracranial abnormality.Age related changes.Patient underwent mri of cervical spine w/wo contrast.Impression: multilevel ddd, worse at c6/7 and c5/6.(b)(6) 2004:patient presented for evaluation of bilateral cts, left more significant than right.Patient has some worn splints and had been dropping objects.Physical examination reveals patient has some decreased sensation in ulnar nerve distribution.Patient is unsteady on foot.Patient has a tremor and myoclonic movements more pronounced in his lue and lle which tend to dissipate with motion.Bilateral hands have decreased sensation.(b)(6) 2004: patient presented with pre-op diagnosis of left carpal tunnel syndrome and underwent division of transverse carpal ligament, decompression of median nerve, left wrist.No complications were reported.(b)(6) 2005: patient underwent anesthesia monitored lumbar mri without contrast due to history of back pain.Patient presented with right leg pain and numbness.Musculoskeletal examinations reveals arthritis, neck and low back problems and parkinson's impressions: degenerative disc disease at l5-s1 with reactive endplate changes.At this level there is a small left paracentral disc protrusion which is not encroaching upon neural elements.2.No other significant abnormalities.Clinical correlation.(b)(6) 2005:patient presented with chief complaint of leg and back pain which radiates to the right hip and knee associated with numbness.Work up revealed moderate to severe lumbar ddd at l5/s1 with left parcentral disc herniation.Patient was admitted for elective surgical management.Patient has a resting tremor with his left arm.Impressions: l-5/s-1, lumbar degenerative disc disease, l-5/s -1, with mechanical back pain and radiculopathy.Diabetes mellitus.(b)(6) 2005:patient presented with pre-op diagnosis of lumbar disc herniation, l-5/s-1, lumbar degenerative disc disease, l-5/s -1, with mechanical back pain and radiculopathy and underwent l-5 and s-1 laminectomy, l-5/s-1 discectomy for decompression, posterior lumbar interbody fusion at l-5/s1 with hourglass inter-body prosthesis and rhbmp-2/acs, pedicle screws from l-5 to s-1.Indications for procedure: patient has mechanical low back pain and left lower extremity radicular pain.Work-up revealed ddd of at least a moderate degree with vacuum disc phenomenon and left paracentral disc protrusion.He had bilateral foraminal stenosis.Per op notes "a 9 x 22 mm distractor with 90 degrees lordosis was chosen as a template which provided good approximation of the end plates and excellent tension across the disc space.The appropriate sized interbody prosthesis was selected and inserted into the interspace under fluoroscopic guidance.The disc space was packed with bicol soaked in recombinant human bone morphogenic protein.The contralateral side was prepared in the usual fashion.An identical graft was placed in that area.Both the exiting and descending nerve roots were well protected during graft insertion.The wound was irrigated copiously.Gelfoam was used for hemostasis.5.5 mm diameter screws were u sed using a 45 mm length at all screws except for the left s1 screw which utilized a 40 screw.The left s-1 screw started more lateral than usual to allow for good bone purchase.However, based on the length, interjectory seemed be well interosseous.Each screw was then probed after tapping and there were no cortical breeches or break through anteriorly.40 mm rods were inserted in the heads of the screws.Caps were applied.There was slight compression across the disc space.Heads of the caps were snapped off.The wound was irrigated copiously"patient was implanted with neuro hourglass vertebral body spacer, screw reduction system, pre-bent rods (b)(6) 2005: patient presented with chief complaint of decreased level of consciousness.Patient complaining of back pain and some fever.Patient is somewhat encephalopathic,dm,hypertension.Patient was admitted to hospital.(b)(6) 2005:patient was discharged.Final diagnosis: wound infection after discectomy, diabetes melitus and hypertension.Per discharge summary patient was transferred to rehab for strengthening and was transferred back to acute care on the 22 for re-exploration of the wound secondary to fever.Wound culture has grown out methicillin resistant staphylococcus aureus and he is on vancomycin, being followed by infectious disease.(b)(6) 2005: patient presented with possible wound infection and underwent re-exploration of lumbar wound.Indications for procedure: post lumbar fusion, patient developed minimal drainage which is purulent in nature.Patient also had pneumonia.He had elevated sed rate and c-reactive protein.Because of the suspicion of infection and presence of hardware, surgical intervention was recommended.(b)(6) 2005:patient with status post lumbar laminectomy with re-exploration of wound for mrsa was transferred to rehab unit.Patient underwent physical, occupational and recreational therapy.Patient required supervision with ambulation with a walker.Patient remained with significant pain in his back and legs.Patient has decreased range of motion of the right leg.Any movement of the right leg and he groans ,grimances and grabs his legs complaining of pain.Impression:walking and self care difficulties secondary to severe back pain,dm ,htn,peptic ulcer disease and osteoarthritis.(b)(6) 2005:patient was implanted with groshong nxt catheter.(b)(6) 2005: patient was discharged.(b)(6) 2005: patient presented for follow up.Patient had superficial wound infection and a prolonged course of antibiotics.Patient complains of occasional intermittent leg pain in his right anterior thigh as well as some numbness.Straight leg raising reveals very tight hamstrings.He has continued resting tremor and rigidity in his left side.Assessment: lumbago.(b)(6) 2005: patient presented for follow up.Patient complains of increasing pain travelling down right anterior and lateral thigh down to knee, shock like pain with numbness.Assessment:lumbago.Narcoti analgesics prescribed.(b)(6) 2006:patient presented for follow up.Patient was having pain down into the right leg which is worse when he walks.Pain started in left leg also.He has some numbness as well that travels in an l4 and possibly l5 distribution.Ct scan shows good placement of his hardware which is intact.Onset of some bone growth through the disc space.He does have moderate to severe spinal stenosis at l4-l5,however which is worse than on previous films.Straight leg raising is positive on the right.He also has significant pain with internal and external rotation.He has increased tone on the right and has a resting tremor in his left hand.(b)(6) 2006: patient presented for follow up.Patient's recent emg was reviewed which shows severe peripheral neuropathy.It was unable to determine the presence or absence of radiculopathy because of changes.His recent ct scan shows significant spinal stenosis at l4-l5.He has slight dorsiflexion weakness in the right foot.Straight leg raising is positive.Has minimal muscle spasm.Radiculopathy superimposed on peripheral neuropathy and muscle relaxants were prescribed.(b)(6) 2006: patient presented with back and leg pain radiating in an l5 distribution on the right.Work up revealed worsening spinal stenosis at l4-5 resulting in symptoms.Because of failure of conservative management in the past, patient requested surgical intervention.Ct scan shows moderate spinal stenosis at l4-5.Impression: lumbar spinal stenosis with radiculopathy and admitted for elective surgical management.(b)(6) 2006: patient presented with pre-op diagnosis of lumbar spinal stenosis and l5 foraminal stenosis with radiculopathy and underwent right l4-l5 laminal foraminotomy , right l5 foraminotomy.Minimal laminal foraminotomy was recommended as there is no indication for fusion.On (b)(6) 2009 patient presented with following admission diagnosis: 1.Cellulitis of the right great toe and forefoot.2.Possible osteomyelitis.On (b)(6) 2009 patient presented for test consultation, because of cellulitis, possible osteomyelitis.Impression: borderline diabetes with cellulitis, doubt osteomyelitis with the mri findings.He was of his toes, pending culture results.On (b)(6) 2009 patient presented for office visit.On (b)(6) 2009 patient presented with following diagnosis: 1.Cellulitis of an open wound in the right foot.2.Status post amputation of the right great toe in (b)(6) 2009.On (b)(6) 2009, patient presented for check-up.On (b)(6) 2009 patient presented with complaint of diarrhea, upset stomach.On (b)(6) 2009 patient underwent x-ray "two view chest".Impressions: no acute cardiopulmonary process.On (b)(6) 2009 patient presented for follow-up visit with pain in the foot and right leg.On (b)(6) 2010 patient underwent x-ray "right foot three views".Impressions: no acute bony abnormality.On (b)(6) 2010 patient presented for follow-up visit.On (b)(6) 2010 patient admitted with chief complaint of redness and ulceration of right 2nd toe.Impressions: cellulitis of the right 2nd toe, status post amputation of the right great toe and 1st metatarsal.On (b)(6) 2010 patient underwent x-ray "right knee".Impressions: minimal degenerative change.No acute bony abnormality.Mri recommended if patient's symptoms persist.On (b)(6) 2010 patient underwent ecg test.Findings: ecg normal.On (b)(6) 2010 patient underwent x-ray "lumbar spine".Findings: multiple surgical clips are present in the upper abdomen.A trace lumbar curve convexed to the right which is unchanged.Questionable slight irregularity of the right l4 transverse process demonstrates no definite interval change.No obvious acute fracture identified.X-ray "right hip" impressions: no acute fracture.On (b)(6) 2010, (b)(6) 2011 patient presented for follow-up visit and medical refill.On (b)(6) 2011 patient presented for follow-up regarding bph, clbp, anxiety disorder, sinus congestion, pressure.On (b)(6) 2011 patient underwent x-ray "sinuses".Impression: no significant plain radiographic evidence of acute sinusitis.On (b)(6) 2011 patient presented for follow-up regarding bilateral leg pain, depression, anxiety, hypertension, hyperlipidemia, neuropathy, and gerd medication refills.On (b)(6) 2011 patient presented for follow-up regarding hypertension, anxiety, chronic leg pain-bilateral, neuropathy, gerd, c/o gout flare-up wants uric acid level ordered.On (b)(6) 2011 patient presented for follow-up regarding right foot pain onset x 1 month.On (b)(6) 2012 patient presented for follow-up because of head congestion onset x 1 week, left great toe is bleeding.On (b)(6) 2012 patient presented for follow-up because of htn, hyperlipidemia, clbp, has ulcers on right foot onset x 3 weeks.On (b)(6) 2012 patient presented for follow-up because of amputation right foot.On (b)(6) 2012 patient presented for follow-up because of htn, depression, anxiety, neuropathy, and gerd.On (b)(6) 2012 patient presented for follow-up because of htn, depression, anxiety, chronic bilateral leg pain, neuropathy, hyperlip idemia, h/o osteomyelitis right foot, increased burning in legs.On (b)(6) 2012 patient presented because of flu vaccine.On (b)(6) 2012 patient presented for follow-up because of dm, htn, hyperlipidemia, clbp, insomnia, depression, anxiety, neuropathy, h/o osteomyelitis right foot.On (b)(6) 2013 patient presented for follow-up because of htn, depression, anxiety, neuropathy, gerd, hyperlipidemia, and glucose is fluctuating onset x 1 month.On (b)(6) 2013 patient presented for follow-up because of depression, anxiety, neuropathy, and sinus headache, and sinus drainage onset x 2 months, wants referral for cataract surgery.On (b)(6) 2013 patient presented for follow-up because of dm, htn, hyperlipidemia, mediport problem, left hip pain, left ear popping, sinus congestion, and headache.On (b)(6) 2013 patient presented for follow-up because of clbp, oa, dm, htn, hyperlipidemia, gad, insomnia.On (b)(6) 2013 patient presented for follow-up because of clbp, neuropathy, gad, left hip pain.On (b)(6) 2013 patient presented for follow-up because of depression, anxiety, and neuropathy.On (b)(6) 2013 patient underwent x-ray "left hip series".Impressions: no acute process.On (b)(6) 2013 patient presented for follow-up because of runny nose, sore throat, headache onset 2x days.On (b)(6) 2013 patient presented for follow-up because of htn, depression, anxiety, having pain in left flank onset x 1 day.On (b)(6) 2013 patient presented for follow-up because of depression, anxiety, clbp, neuropathy, dm, htn, sinus drainage onset x 2 months.On (b)(6) 2013 patient presented for follow-up because of anemia, dm, htn, hyperlipidemia, clbp, neuropathy, insomnia, and diarrhea.On (b)(6) 2013 patient underwent ct scan of the abdomen and pelvis without contrast.Impressions: no hydronephrosis or nephrolithiasis.On (b)(6) 2013 patient presented for follow-up because of dm, htn, hyperlipidemia, clbp, chronic bilateral leg, pain/neuropathy, insomnia, gad, congestion/sinus pressure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5083463
MDR Text Key26074129
Report Number1030489-2015-02402
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 08/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7510800
Device Lot NumberM115001AAF
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/24/2015
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) Required Intervention;
Patient Weight102
-
-