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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 7510800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bronchitis (1752); Edema (1820); Fatigue (1849); Fever (1858); High Blood Pressure/ Hypertension (1908); Laceration(s) (1946); Pain (1994); Loss of Range of Motion (2032); Burning Sensation (2146); Dizziness (2194); Depression (2361); Fungal Infection (2419); Sleep Dysfunction (2517)
Event Type  Injury  
Manufacturer Narrative
(b)(6).(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.
 
Event Description
It was reported that on (b)(6) 2004: the patient underwent mri lumbar spine.Impression: l5-s1: anular bulge with a tiny anular tear and shallow central disk protrusion/herniation without definite nerve root impingement or focal stenosis.(b)(6) 2004: the patient presented with low back pain and leg pain.The patient underwent mri.Assessment: l5-s1 disc abnormality is probably producing this patient's current symptoms but not enough to say that she definitely needs to have surgery.That is certainly a concern but i want to treat her conservatively for as long as possible.Oral anti-inflammatories are reasonable.See her back in the office in the future if she still has problems.(b)(6) 2004: the patient presented with pre-operative diagnosis of appendicitis and underwent procedure.(b)(6) 2008: the patient underwent lumbar diskogram.Impression: provocative discogram reproduced the patient's back and left leg pain at the l5-s1 level.(b)(6) 2004: the patient presented with back pain, pain in left leg.The patient underwent x-ray.Assessment: l5 s-1 degenerative disc disease with severe back pain and left leg pain.(b)(6) 2004: the patient underwent xr chest pa and lateral.Findings: cardiac size and contour are normal.Lungs are clear and well expanded" bones, soft tissues, and diaphragm are unremarkable.(b)(6) 2004: the patient presented with degenerative disc disease l5-s1 and underwent l5 anterior exposure of the lumbar spine with spinal decompression/fusion and placement of interbody fusion devices, anterior plate system, diskectomy, intraoperative fluoroscopy.Per op notes: a skin incision made in a semi pfannenstiel incision to the old pfannenstiel incision on the left side, carried down to scar tissue to the anterior rectus sheath, which is incised vertically.The muscles elevated and the posterior sheath is dissected laterally exposing the retroperitoneum.The dissection carried pulling the peritoneal cavity to patient's right, exposing the lumbar disc at l5-s1.Long retractors were placed and the dissection over the disc was accomplished using blunt dissection only.Crossing vessels identified elevated and clipped x2 and divided with scissors.The remainder of the dissection blunt dissection exposing the entire anterior aspect_ the midline was identified with an olive tip k-wire fluoroscopy.Diskectomy was performed after marking the midline and this was performed with 15 knife blade curettes and rongeurs.After removal of the disc, the drill tube was placed over the midline distraction device and the reamer was used followed by the tap.Irrigation.Cage was packed with rh-bmp2/acs and inserted into the patient's right side of the midline tube and placed in the disc space under biplanar fluoroscopy.The contralateral side was also done in a similar fashion.(b)(6) 2004: the patient underwent three-view lumbar spine.Impression: anterior plate and screws at l5 and s1.(b)(6) 2004: the patient was discharged.The patient presented with admission diagnosis of back pain and underwent anterior lumbar interbody fusion.(b)(6) 2004, (b)(6) 2004: the patient presented with pain in legs.(b)(6) 2004, (b)(6) 2004: the patient presented with radicular type pain on left side and back pain.(b)(6) 2005: the patient was presented with radicular type pain down her left leg and limited range of motion of the lumbar spine.Assessment: continuing some back pain and radicular pain down the left leg statuspost anterior interbody fusion at l5 with evidence on x-ray of maturing fusion.(b)(6) 2009: the patient underwent x-ray of pelvis.Impression: l5-s1 hardware, ususual colied metallic density over the right region intermediate etiology.(b)(6) 2009: the patient presented with depression.(b)(6) 2009: the patient presented with follow up visit.(b)(6) 2009, (b)(6) 2010, (b)(6) 2010: the patient presented with hip pain.(b)(6) 2010: the paint presented with leg pain.(b)(6) 2010: the patient presented with yeast infection and burning during urination.(b)(6) 2010: the patient presented with fever and back pain.The patient underwent urine examination.Ros revealed: psych : depression and anxiety.(b)(6) 2010: the patient presented with chief complaint of carpal tunnel in waist.(b)(6) 2010: the patient presented with pain in low back and stone.(b)(6) 2010: the patient presented with pain and sleep disorder.(b)(6) 2010, (b)(6) 2010: the patient presented for follow-up.(b)(6) 2010: ros revealed: psych: depression and anxiety.(b)(6) 2010: the patient presented for medicine refills.(b)(6) 2010, (b)(6) 2010: the patient presented with hip pain.(b)(6) 2010: the patient presented with dizziness and fatigue.(b)(6) 2011: the patient presented with wrist pain.(b)(6) 2011: the patient presented with chief complaint of follow- up medications and requesting referral.The patient underwent physical examination as it revealed: hip pain, abdominal pain, wrist pain, anxiety (b)(6) 2011: the patient presented with chief complains of lumbosacral back pain also have some radiation towards inner thigh.The patient underwent x-ray revealed: reviewed which demonstrate general lumbar scoliosis.Patient does have a healed l5-s1 anterior spinal fusion she does have vascular coil noted in the right groin area she does have facet arthropathy at l4-5 and l5-s1 no lytic or blastic processes no gross instability on flexion and extension views.(b)(6) 2011: the patient presented with chief complains of follow up/ labs done in (b)(6).The patient underwent physical examination: psych: depressed affect and anxious.No overt psychotic features.Impression: hip pain, diarrhea, abdominal pain.(b)(6) 2011: the patient presented with chief complaint of physical.The patient underwent physical examination.Neurological: no focal deficits, cranial nerves ii-xii grossly intact with normal sensation, reflexes, coordination, muscle strength and tone.Psych: clearer today and cheerful.Impression: wrist pain, hip pain.(b)(6) 2011: the patient underwent radiology examination.Impression: no mammographic evidence of malignancy, as above.I recommend routine follow-up, as indicated, birads category 2: benign.(b)(6) 2011: the patient presented with chief complaint of med refills and ear ache.Ros revealed: ms joint and back pain.Impression: ear pain, chronic pain syndrome, osteoporosis.(b)(6) 2011: the patient presented for follow up visit.(b)(6) 2011: the patient presented with a chief complaint of medication refill.Ros revealed: ms: joint and back pain.Psych: anxiety and depression.Impression: chronic pain syndrome.(b)(6) 2011: the patient presented with chief complaint of back pain.Ros revealed: ms joint and back pain.Physical examination revealed: msk: slr's normal.Tender right s1 joint with some surrounding spasm.Antalgic, neurologic: no focal deficits, cranial nerves ii-xii grossly intact with normal sensation, reflexes, coordination, muscle strength and tone.Impression: sacroiliitis, chronic pain syndrome, (b)(6) 2011: the patient underwent esophagogastroduodenoscopy procedure.(b)(6) 2011: the patient presented for follow up visit.Ros revealed: ms: joint and back pain.Physical examination revealed: msk: tender right si joint area as before.Neuro, slr's negative.Neurologic: no focal deficits, cranial nerves ii-xii grossly intact with normal sensation, reflexes, coordination, muscle strength and tone.Psych: depressed affect and anxious.But relational, some humor, and very much better than she was before seeing bh here.Impression: acute sacroiliitis, chronic pain syndrome, (b)(6) 2011: the patient presented for follow-up visit.(b)(6) 2011: the patient presented with chief complaint of r hand cut and r hand infection.Physical examination revealed.Impression: laceration hand right, vaginal candidiasis (b)(6) 2011: the patient presented with chief complaint of needs referral.Ros revealed: ms: joint pain and back pain.Psych: anxiety.Impression: zenker diverticulum, back pain, candidiasis vaginal, health maintenance exam.(b)(6) 2011: the patient presented with follow-up visit.Ros revealed: ms: back pain, neuro : headache.Physical examination revealed: neurologic: no focal deficits, cranial nerves ii-xii grossly intact with normal sensation, reflexes, coordination, muscle strength and tone.Psych: anxious, emotional liability, no sih ideation, and no hallucinations.Impression: back pain, chronic pain syndrome.(b)(6) 2011: the patient presented for follow-up.Ros revealed, ms: back pain.Physical examination revealed: msk: tender point over right sij.Normal slr's.Minimal low back rom.Neurologic: no focal deficits, cranial nerves ii-xii grossly intact with normal sensation, reflexes, coordination, muscle strength and tone.Impression: back pain, sacroiliitis.(b)(6) 2011: the patient presented with chief complaint of back pain.Ros revealed: ms: back pain and stiffness.Physical examination revealed: msk: tender point over right sij.No cellulitis normal slr's.Minimal low back rom.Neurologic: no focal deficits, cranial nerves ii-xii grossly intact with normal sensation, reflexes, coordination, muscle strength and tone.Psych: anxious, emotional lability, no s/h ideation, and no hallucinations.Impression: back pain, chronic pain syndrome.(b)(6) 2012: the patient presented for follow-up visit.Ros revealed: ms: joint pain, back pain and stiffness.General examination revealed: msk: slow and antalgic.Psych: depression affect, anxious, a<(>&<)>ox3, no s/h ideation and no hallucinations.Impression: back pain, chronic pain syndrome.(b)(6) 2012, (b)(6) 2012: the patient presented for follow-up visit with increased anxiety.(b)(6) 2012: the patient presented with chief complaint of back pain.Ros revealed: ms: joint pain, back pain and stiffness.Psych: anxiety and depression.Impression: back pain, health maintenance exam, chronic pain syndrome, osteoporosis, hip pain, tobacco abuse.(b)(6) 2012: the patient presented with chief complaint of f/u on back pain.Ros revealed ms: back pain, psych: anxiety and depression.Impression: back pain.(b)(6) 2012: the patient presented for follow-up visit.(b)(6) 2012: the patient presented with chief complaint of pain, blood, and burning with urination.Ros revealed: ms : back pain.Impression: candidiasis, vaginal, back pain, (b)(6) 2012: the patient presented with chief complaint of vaginal bleeding.Ros revealed: ms: joint and back pain.Underwent physical examination.Neurological: no focal deficits, cranial nerves ii-xii grossly intact with normal sensation, reflexes, coordination, muscle strength and tone.Psych: flat affect and no s/h ideation.Impression: sleep disorder, edema, lipoma, abnormal vaginal bleeding (b)(6) 2012: the patient presented for follow-up visit.(b)(6) 2012: the patient presented for follow-up visit.Underwent physical examination; impression: postmenopausal atrophic vaginitis, (b)(6) 2013: the patient presented for follow-up visit.Physical examination revealed: psych: depressed affect, flat affect, no s/h ideation, and no hallucinations.Impression: ureterolithiasis, gastroesophageal reflux disease, nausea, (b)(6) 2013: the patient presented for follow-up visit.(b)(6) 2013: the patient presented for follow-up, underwent physical examination.Impression: ureterolithiasis, acute bronchitis, (b)(6) 2013: the patient presented with follow-up visit.Physical examination revealed: ureterolithiasis, cold sore, (b)(6) 2013: the patient presented for follow-up visit.Physical examination revealed: msk: right lateral heel slightly puffy, no cr epitus, tenderness or deformity.Psych: anxious, easily distracted, no s/h ideation, and no hallucination.Impression: gastroesophageal reflux disease, tobacco abuse, hip pain, nausea, (b)(6) 2013: the patient presented for follow-up.General examination revealed: neuro : headache, psych: anxiety and depression.Impression: hypertension, headache, (b)(6) 2013: the presented for follow-up visit.General examination revealed: neuro difficulty with concentration.Psych: poor sleep.Impression: memory loss, accidental fall, headache, hypertension.The patient underwent mri head without and with iv contrast.Impression: no acute intracranial process on this examination as described, at the edge of the field, findings suggest moderate asymmetric spondylosis or disc herniation to the right at c4-c5.If indicated a dedicated cervical spine mri to further evaluate.(b)(6) 2013: the patient presented for follow-up visit.Ros revealed: neuro: complaint of headaches.The patient underwent physical examination; revealed: neurologic: no focal deficits, cranial nerves ii-xii grossly intact with normal sensation, reflexes, coordination, muscle strength and tone.Psych: anxious.Impression: hypertension, memory loss, back pain, headache, anxiety.
 
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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 Key5073654
MDR Text Key25624195
Report Number1030489-2015-02324
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 08/17/2015
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
Device Catalogue Number7510800
Device Lot NumberM112001ABC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/17/2015
Initial Date FDA Received09/14/2015
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 Weight75
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