|
MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
|
Back to Search Results |
|
| Catalog Number 7510200 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Ossification (1428); Fever (1858); Bone Fracture(s) (1870); Incontinence (1928); Nausea (1970); Neuropathy (1983); Pain (1994); Pneumonia (2011); Swelling (2091); Vomiting (2144); Weakness (2145); Chills (2191); Dizziness (2194); Hernia (2240); Stenosis (2263); Ulcer (2274); Depression (2361); Inadequate Pain Relief (2388); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
|
|
Event Type
Injury
|
|
Event Description
|
|
It was reported that the patient underwent a spine fusion surgery at l5 to s1 using rhbmp-2/acs.The patient's post-operative period was marked by a period of relief followed by ectopic bone growth and increasingly severe pain and weakness in his lower extremities along with episodes of bowel incontinence.Currently, patient continues to experience severe and unrelenting pain that radiates into his lower extremities.The severity of the pain causes chills and vomiting.
|
| |
|
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.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2011, the patient underwent transforaminal lumbar interbody fusion.The rhbmp-2 and coroent cage were used in the patient.The patient had bilateral pars defect, lumbar instability, l5-s1 nerve root irritation causing chronic low back pain that would lead to the surgery.In (b)(6) 2009, the patient underwent exploratory hernia surgery.From (b)(6) 2012, the patient had nausea/vomiting.From 2010-2013, the patient had back pain and rhbmp-2/acs surgery.From 2010-2015, the patient presented for diabetes.In 2011, the patient was treated for back pain and pre- rhbmp-2/acs surgical evaluation.From 2013-2014, the patient visited primary care nurse practitioner post-op, the patient had experienced radiating pain to legs and lumbar region of back.The patient complained of back pain that sometimes radiates into abdomen and/or lower extremities.The patient had trouble in sleeping or bending down.Also the pains got worsen on sitting and walking.The patient could not lift much heavy weight and had difficulty in sleeping and walking long distances.On (b)(6) 2011 patient presented for follow-up and reported lower back pain radiating to his bilateral lower extremities, muscle pain in groin and secondary pain higher up in the back.On (b)(6) 2011 patient underwent mri lumbar.Impression: interval postoperative changes of posterior rod and pedicle screw fusion from l5-s1.No anteriolisthesis at this level.The bilateral pars defect at l5 was better demonstrated on a prior ct scan; bilateral neuroforaminal narrowing at l5-s1, which is moderate to severe on the left and has increased slightly in the interval; no definite enhancing granulation tissue at the operative site; however, evaluate evaluation is limited due to the lack of iv contrast; no central canal narrowing.On (b)(6) 2011 patient presented for pre-op evaluation.On (b)(6) 2011 patient underwent the following procedures: l5-s1 left sided transforaminal decompression; l5-s1 left sided transforaminal interbody fusion; bone morphogenic protein, local bone graft and conduit bone graft extender used for this fusion; insertion of biochemical device, l5-s1, coroent cage; posterior instrumented fusion using the viper2 system; posterior intertransverse fusion, l5-s1.Operative procedure: the annulus fibrosis was opened with a 15 blade.Pituitary forceps and ringed curets were used to remove most of the disk.The endplate was prepared for the fusion with a ringed curet and a cup curet.An 8mm coroent cage filled with bmp and conduit bone graft extender were inserted.The disk space was packed with conduit bone graft extender.No complications were reported.Patient presented for post-surgical consultation.On (b)(6) 2011 patient underwent x-ray lumbar spine.Impression: fusion l5-s1 patient presented for follow-up and reported lower back pain and bilateral lower extremities.On (b)(6) 2011 patient presented for follow-up and reported lower back pain.Patient underwent x-ray lumbar spine for back pain.Impression: stable well seated posterior fusion l5-s1.On (b)(6) 2011 patient underwent x-ray lumbar spine.Impression: stable well seated posterior fusion l5-s1 on (b)(6) 2011 patient presented for follow-up and reported lower back pain and lower extremity swelling.On (b)(6) 2011 patient underwent x-ray lumbar spine.Impression: stable well seated posterior fusion l5-s1 patient presented for follow-up and reported lower back pain.On (b)(6) 2011 patient presented for follow-up complaining of back pain.On (b)(6) 2011 patient presented for follow-up complaining of lumbar strain.On (b)(6) 2011 patient presented for follow-up complaining of back pain and neck pain.Patient underwent x-ray lumbar spine and x-ray thoracic spine.Impression: stable postoperative changes.No acute bony findings.On (b)(6) 2011 patient underwent x-ray lumbar spine.Impression: stable well seated posterior fusion l5-s1 patient presented for follow-up and reported intermittent lower back pain.On (b)(6) 2011 patient presented for triage complaining of back pain.On (b)(6) 2011 patient underwent x-ray lumbar spine.Impression: stable well seated posterior fusion l5-s1 on (b)(6) 2011 patient presented for follow-up and reported chronic and acute lower back pain and abdominal pain.On (b)(6) 2012 patient presented for follow-up and reported chronic and acute lower back pain and abdominal pain.On (b)(6) 2012 patient presented for follow-up and reported chronic and acute lower back pain on (b)(6) 2012 patient presented for office visit complaining of back pain and probable inguinal hernia.On (b)(6) 2012 patient presented for triage complaining of back pain on (b)(6) 2012 patient underwent x-ray lumbar spine.Impression: stable well seated posterior fusion l5-s1 patient presented for follow-up and reported lower back pain.Patient was admitted to the hospital and reported throbbing lower back pain radiating down bilateral lower extremities down to his ankle.The pain was reported as constant and was worse while sitting or walking.On (b)(6) 2012 patient was admitted and reported lower back pain.On (b)(6) 2012 patient was admitted and diabetes was brought under control.On (b)(6) 2012 patient was admitted for nausea with vomiting of gastric contents, diffuse abdominal pain, cold and fever.On (b)(6) 2012 patient was admitted and diabetes was brought under control.He reported vomiting for 3 days and had some dark colored emesis.On (b)(6) 2012 patient was admitted after a fall resulting in back and ribs pain.On (b)(6) 2012 patient presented for office visit.He had an infected bite on shoulder and fractured ribs.Patient underwent x-ray ribs.Impressions: acute fractures on 6th, 7th and 8th ribs.On (b)(6) 2012 patient was admitted with chief complaint of back pain.On (b)(6) 2013 patient was admitted with chief complaint of back pain.On (b)(6) 2013 patient presented for triage complaining of back pain and swollen upper lip.On (b)(6) 2013 patient was admitted with chief complaint of back pain.On (b)(6) 2013 patient was admitted with chief complaint of nausea, headache, vomiting and his diabetes was controlled.On (b)(6) 2013 patient was admitted with chief complaint of back pain.On (b)(6) 2013, (b)(6) 2012, (b)(6) 2011, (b)(6) 2010, patient presented for office visit and reported lower back and occasional radiation into bilateral legs.On (b)(6) 2013 patient underwent ct lumbar spine.Impressions: l5-s1 hardware appears intact with no complication in the interval.Left greater than right neutral foraminal narrowing present.Mild degenerative change si joints.Some minimal degenerative change l4-5 level.Patient presented for follow-up and was sent for ct.On (b)(6) 2013 patient was admitted with chief complaint of bite to right arm.On (b)(6) 2013 patient was admitted with chief complaint of foot and ankle pain and swelling.On (b)(6) 2013 patient was admitted with chief complaint of right foot pain.On (b)(6) 2013 patient was admitted with chief complaint of flare up of chronic low back pain.On (b)(6) 2013 patient was admitted with chief complaint of low back pain.On (b)(6) 2013 patient was admitted with chief complaint of acute exacerbation of low back pain.On (b)(6) 2013 patient was admitted with chief complaint of increased low back pain.On (b)(6) 2013 patient was admitted with chief complaint of ongoing back pain.On (b)(6) 2014 patient presented for follow-up on his chronic back pain.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
Per medical records it was reported that on: (b)(6) 2007 patient underwent "abdomen compl.W/iv chest.Total dx x-ray".On (b)(6) 2008 patient underwent ct of head without contrast total ct scan-head, ct spine cervical w/o contrast total ct scan-body.On (b)(6) 2009, the patient had mri brain.Impression : negative.On (b)(6) 2013 patient was admitted with chief complaint of right foot pain.Patient underwent right ankle radiography- cr leg tibia fibula ap and lat right and ct abdomen and pelvis with contrast.Impression : stress reaction suspected at the calcaneus.On (b)(6) 2014 , the patient underwent head ct.Impression : normal.On (b)(6) 2009, patient presented due to his groin muscle pull.Impression: groin muscle strain.Impression: bilateral inguinal pain seems to be consistent with muscle strain.On (b)(6) 2009 patient presented due to his groin muscle pull.Impression: groin muscle strain, ligamental strain, possible hernia.On (b)(6) 2009 patient presented due to bilateral inguinal or groin strain.Impression: bilateral inguinal strains.On (b)(6) 2009 patient presented due to bilateral testicular discomfort.On (b)(6) 2009 patient presented due to bilateral groin pain.On (b)(6) 2009 patient underwent diagnostic laparoscopy to treat bilateral groin pain.On (b)(6) 2009 patient called due to rash.On (b)(6) 2009 the patient presented post diagnostic laparoscopy for evaluation of possible inguinal hernias in which time to hernias were identified.The patient states he had some groin pain with activity but he also does have some chronic back pain.On (b)(6) 2009 patient presented (b)(6) 2009 patient underwent ct scan of lumbar spine was reviewed.There was evidence of bilateral pars defect at l5-s1 without significant nerve root compression.Impression: the surgeon was not sure if pars defect can be blamed for his symptomatology.On (b)(6) 2009 patient underwent mri lumbar spine w/o dye.On (b)(6) 2009 the patient presented for an office visit due to pain.Impression: bilateral pars defect, lumbar 5-sacral 1, with improvement post epidural steroid injection 2 weeks from esi.On (b)(6) 2009 the patient presented for an office visit.Impression: satisfactory result injection.On (b)(6) 2010, the patient presented with complaint of chronic pain.On (b)(6) 2010, the patient presented for medicine refill and annual exercise education.On (b)(6) 2010, the patient presented for follow up of his abdominal pain, nausea and diarrhea and evaluation.On (b)(6) 2010 patient presented for an office visit due to abdominal discomfort.Impression: mild abdominal discomfort, probably related to abdominal muscle strain.Patient does not appear to have any signs of infection or any inflammatory processes.On (b)(6) 2012: the patient presented with chief complaint of chronic low back pain.The patient underwent physical examination.Musculoskeletal: patient has moderate tenderness with palpitation to lumbar spine throughout and mild tenderness noted to paraspinous muscles.On (b)(6) 2012: the patient presented for follow up on back pain.The patient underwent physical examination.Musculoskeletal: moderate tenderness noted with palpitation to lumbar spine throughout.On (b)(6) 2013, (b)(6) 2012: the patient presented with chief complaint of chronic back pain.The patient underwent physical examination.Musculoskeletal: moderate tenderness noted with palpitation to lumbar spine throughout.On (b)(6) 2013: the patient presented with chief complaint of back issues.The patient underwent physical examination.Musculoskeletal: moderate tenderness noted with palpitation to lumbar spine throughout.On (b)(6) 2013: the patient underwent mri lumbar w/wo.Impression: interval postoperative changes of posterior rod and pedicle screw fusion from l5 through sl.No anterolisthesis at this level.The bilateral pars defects at l5 were better demonstrated on a prior ct scan; bilateral neuroforaminal narrowing at l5-s 1, which is moderate to severe on the left and has increased slightly in the interval; no definite enhancing granulation tissue at the operative site; however,bnevaluate evaluation is limited due to the lack of iv contrast; no central canal narrowing.On (b)(6) 2013: the patient presented with chief complaint for follow up after mri and increase in pain.The patient underwent physical examination.Musculoskeletal: moderate tenderness noted with palpitation to lumbar spine throughout, patient was unable to flex and extend his lumbar spine due to the svere pain.On (b)(6) 2013: the patient presented with chief complaint of chronic low back pain.The patient underwent physical examination.Musculoskeletal: mild tenderness noted with palpitation to lumbar spine throughout.Mild pain noted with flexion and extension of lumbar spine with no limitation noted.On (b)(6) 2013: the patient presented with chief complaint of low back pain.The patient underwent physical examination.Musculoskeletal: moderate pain was elicited with flexion and extension of lumbar spine.On (b)(6) 2013: the patient presented with chief complaint of follow up after neuro- surgery appointment.The patient underwent physical examination.Musculoskeletal: mild tenderness noted with palpitation to lumbar spine throughtout.Mild pain with flexion and extension of lumbar spine with no limited noted.On (b)(6) 2013: the patient presented with chief complaint of increase in back pain.The patient underwent physical examination.Musculoskeletal: moderate tenderness noted with palpation to lumbar spine throughout.Severe pain noted with flexion and extension of lumbar spine with no limitation noted.On (b)(6) 2013 , the patient presented with c /o lower back pain x 2 days, states hx l5 fx, spinal fusion surgery x 2 yrs ago.The patient requested injection to deltoids and was given ketorolac tromethamine 30mg (b)(6) 2013: the patient presented for follow up on recent medication change.The patient underwent physical examination.Musculoskeletal: mild tenderness noted with palpitation to lumbar spine throughtout.Mild pain with flexion and extension of lumbar spine with no limited noted.On (b)(6) 2013: the patient presented with chief complaint of back pain.The patient underwent physical examination: musculoskeletal mild tenderness noted with palpitation to lumbar spine throughtout.Moderate pain with flexion and extension of lumbar spine with no limited noted.On (b)(6) 2013: the patient presented with chief complaint of back pain.The patient underwent physical examination.Musculoskeletal: mild tenderness noted with palpitation to lumbar spine throughtout.Mild pain with flexion and extension of lumbar spine with no limited noted.On (b)(6) 2013: the patient underwent physical examination: musculoskeletal: minimal tenderness noted with palpitation to lumbar spine throughtout.Mild pain with flexion and extension of lumbar spine with no limited noted.On (b)(6) 2013 <(>&<)> (b)(6) 2014 , the patient presented for laboratory examination/ submitting sample.He requested medicine refill.He was referred to neuro and pain management.On (b)(6) 2014, patient presented with depression and requested for referral.Patient had chronic back pain due to l5-s1 spinal fusion.On (b)(6) 2014, the patient presented with lower back pain and bowel movement problem.Type of injury:the location where the incident occurred was unknown.Location: bilateral lumbar.Radiating pain: right lower extremity, right buttock.He underwent mri.Magnetic resonance imaging, lumbar spine, reviewed radiologist report, interpretation: no evidence of significant spinal canal stenosis; status post bilateral pedicle screw fusion from l5 to 81 with disk spacers in place.The canal at this level and right foramen are unremarkable.The left ls-81 foramen does demonstrate mild to moderate foraminal narrowing likely secondary to bony irregularity along the edge of the adjacent facet joint.A focal disk protrusion is not identified (b)(6) 2014, the patient presented with chief complain of stubbed his right foot last night, thinks he broke his right great toe, is black and blue under the nail bed.Per patient , he was getting light headed, dizzy, blood pressure is lower than he usually runs.On (b)(6) 2014, the patient presented at the er in (b)(6) yesterday, fractured left wrist/thumb.Patient requesting referral for surgery.The patient was asked to underwent x-ray exam of figure and hand.On (b)(6) 2014, the patient underwent following procedures: thumb spica splint; digital block for postoperative pain.On (b)(6) 2014, the patient presented for follow up on his left first metacarpal injury.Assessment : right thumb fracture, healing.On (b)(6) 2014, the patient presented with diabetes mellitus , opioid abuse, multiple site arthropathy.Assessment : left hand fracture of thumb.On (b)(6) 2014, (b)(6) 2013: the patient presented with chief compliant of chronic low back pain.The patient underwent physical examination.Musculoskeletal: mild tenderness noted with palpitation to lumbar spine throughtout.Mild pain with flexion and extension of lumbar spine with no limited noted.On (b)(6) 2014 , the patient presented for follow up of status post left first metacarpal injury.The patient underwent: left hand thumb metacarpal fracture open reduction plate ftxation; thumb spica splint.Patient had x-ray figure thumb left.Impression : interval removal of hardware with partial healing, correlate findings at the time of the procedure.On (b)(6) 2014, the patient made visit for medicine refill.On (b)(6) 2014, the patient admitted with nausea, vomiting, hyperglycemia.The patient underwent ct abdomen/ pelvis.Impression ; no acute inflammatory process in the abdomen or pelvis.No urolithiasis; small focal area of consolidation in the medial left lower lobe.On (b)(6) 2014, the patient presented with complaint of early pneumonia.On (b)(6) 2014: the patient presented for follow up on back.The patient underwent physical examination.Musculoskeletal: moderate pain noted with palpitation to the lumbar spine throughout.Moderate to severe pain with flexion and extension of the spine with no limitation noted.On (b)(6) 2012, the patient presented for follow up of low back pain (b)(6) 2013 the patient presented due to back pain acute on chronic.Assessment: acute on chronic back pain.On (b)(6) 2015, the patient presented with degenerative changes in the midfoot.Underwent x ray.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2009: patient underwent x-ray of lumbar spine.On (b)(6) 2009: patient underwent ct of lumbar spine.On (b)(6) 2011: patient underwent ct of lumbar spine.On (b)(6) 2010, (b)(6) 2011: patient presented for office visit.On (b)(6) 2011: patient presented for office visit and underwent blood study.On (b)(6) 2011: patient underwent x-ray cervical spine and chest.On (b)(6) 2011: patient underwent a therapeutic procedure.On (b)(6) 2012: patient was admitted and underwent x-ray radiological study.On (b)(6) 2012: patient was discharged.On (b)(6) 2012: patient presented for e/r visit.On (b)(6) 2012 patient presented for office visit.He had an infected bite on shoulder and an injury to the left anterolateral lower ribs resulting in multiple fractured ribs.On (b)(6) 2013: patient presented for e/r visit.On (b)(6) 2013: patient presented for office visit and reported low back pain from side to side travelling down his buttocks bilaterally to the toes.On (b)(6) 2015: patient presented for office visit and reported pain in his left great toe with blister.The toe became red, swollen and tender.On (b)(6) 2015: patient presented for office visit and reported pain in his left great toe with blister which was debrided.On (b)(6) 2015: patient presented for office visit for ongoing problems with foot ulcer which was debrided but was getting worse.On (b)(6) 2015: patient presented for office visit with complaint of left hallux wound.On (b)(6) 2015: patient presented for office visit for recheck on left big toe wound.On (b)(6) 2015: patient presented for office visit for ongoing problems with foot ulcer where his toe was more swollen and had drainage.He had also noticed a malodor on the toe.On (b)(6) 2015: patient presented for office visit for ongoing problems with foot ulcer.
|
| |
|
Manufacturer Narrative
|
|
If information is provided in the future, a supplemental report will be issued.
|
| |
|
Event Description
|
|
It was reported that on: (b)(6) 2011, the patient presented with the following pre-op diagnosis: chronic low back pain, bilateral pars defect, lumbar instability, failure of extensive medical management, l5-s1 left sided nerve root irritation.On (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012: the patient presented with chief complaint of chronic low back pain.The patient underwent physical examination.Musculoskeletal: patient has moderate tenderness with palpitation to lumbar spine throughout and mild tenderness noted to paraspinous muscles.On (b)(6) 2012: the patient presented for follow up on back pain.The patient underwent physical examination.Musculoskeletal: moderate tenderness noted with palpitation to lumbar spine throughout.On (b)(6) 2013, (b)(6) 2012: the patient presented with chief complaint of chronic back pain.The patient underwent physical examination.Musculoskeletal: moderate tenderness noted with palpitation to lumbar spine throughout (b)(6) 2013: patient presented due to low back pain.Assessment: low back pain, status post previous back surgery, with radicular type symptoms down both legs.On (b)(6) 2013: the patient presented with chief complaint of back issues.The patient underwent physical examination.Musculoskeletal: moderate tenderness noted with palpitation to lumbar spine throughout.On (b)(6) 2013: the patient underwent mri lumbar w/wo.Impression: interval postoperative changes of posterior rod and pedicle screw fusion from l5 through sl.No anterolisthesis at this level.The bilateral pars defects at l5 were better demonstrated on a prior ct scan.Bilateral neuroforaminal narrowing at l5-s1, which is moderate to severe on the left and has increased slightly in the interval.No definite enhancing granulation tissue at the operative site; however,bnevaluate evaluation is limited due to the lack of iv contrast.No central canal narrowing.On (b)(6) 2013: the patient presented with chief complaint for follow up after mri and increase in pain.The patient underwent physical examination.Musculoskeletal: moderate tenderness noted with palpitation to lumbar spine throughout, patient was unable to flex and extend his lumbar spine due to the svere pain.On (b)(6) 2013, (b)(6) 2013: the patient presented with chief complaint of chronic low back pain.The patient un derwent physical examination.Musculoskeletal: mild tenderness noted with palpitation to lumbar spine throughout.Mild pain noted with flexion and extension of lumbar spine with no limitation noted.On (b)(6) 2013: the patient presented with chief complaint of low back pain.The patient underwent physical examination.Musculoskeletal: moderate pain was elicited with flexion and extension of lumbar spine.On (b)(6) 2013: the patient presented with chief complaint of follow up after neuro- surgery appointment.The patient underwent physical examination.Musculoskeletal: mild tenderness noted with palpitation to lumbar spine throughtout.Mild pain with flexion and extension of lumbar spine with no limited noted.On (b)(6) 2013, (b)(6) 2013 : the patient presented with chief complaint of back pain.The patient underwent physical examination.Musculoskeletal: mild tenderness noted with palpitation to lumbar spine throughtout.Mild pain with flexion and extension of lumbar spine with no limited noted.On (b)(6) 2013: the patient presented with chief complaint of increase in back pain.The patient underwent physical examination.Musculoskeletal: moderate tenderness noted with palpation to lumbar spine throughout.Severe pain noted with flexion and extension of lumbar spine with no limitation noted.On (b)(6) 2014, (b)(6) 2014, (b)(6) 2013: the patient presented with chief compliant of chronic low back pain.The patient underwent physical examination.Musculoskeletal: mild tenderness noted with palpitation to lumbar spine throughtout.Mild pain with flexion and extension of lumbar spine with no limited noted.On (b)(6) 2013: the patient presented for follow up on recent medication change.The patient underwent physical examination.Musculoskeletal: mild tenderness noted with palpitation to lumbar spine throughtout.Mild pain with flexion and extension of lumbar spine with no limited noted.On (b)(6) 2013: the patient presented with chief complaint of back pain.The patient underwent physical examination: musculoskeletal mild tenderness noted with palpitation to lumbar spine throughtout.Moderate pain with flexion and extension of lumbar spine with no limited noted.On (b)(6) 2013: the patient underwent physical examination: musculoskeletal: minimal tenderness noted with palpitation to lumbar spine throughtout.Mild pain with flexion and extension of lumbar spine with no limited noted (b)(6) 2014: the patient presented for follow up on back.The patient underwent physical examination.Musculoskeletal: moderate pain noted with palpitation to the lumbar spine throughout.Moderate to severe pain with flexion and extension of the spine with no limitation noted.
|
| |
|
Search Alerts/Recalls
|
|
|
