• 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 Calcium Deposits/Calcification (1758); Cyst(s) (1800); Swollen Lymph Nodes (2093); Thyroid Problems (2102); Hernia (2240)
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.
 
Event Description
It was reported that on (b)(6) 2005, the patient underwent a surgery with diagnosis of l5-s1 recurrent disk herniation and l5-s1 degenerative disk disease.Operation performed: left l5-s1 transforaminal lumbar interbody fusion with allograft.Partial sl corpectomy.Placement of interbody cage, l5-s1, using a peek cage.Posterior fusion, l5-s1, using autograft.Nonsegmental instrumentation to l5-s1 using screws.Microscope for microdissection.Intraoperative fluoroscopy greater than an hour.Iliac crest bone graft through a separate incision.Two hours continuous emg monitoring.Per op-notes, the surgeon performed a complete diskectomy and prepared the interbody space for fusion, removing all the cartilaginous endplates down to bleeding bone.Once the interbody space was properly prepared, the surgeon then sized and placed an interbody cage using a peek interbody device.I placed the bone morphogenic protein in the middle of the device and then harvested an iliac crest bone graft through a separate incision using reamers, mixed this with another part of the bmp sponge and packed this on the opposite side of the peek cage.This was used for fusion; screws at l5 and s1 and checked the positioning under c-arm fluoroscopy.The surgeon then exposed the right-hand side, decorticated the facet, the lamina, the pars of l5 and s1, and packed the remaining bone morphogenic protein and iliac crest bone for a posterior fusion of l5-s1.The proper positioning of the screws and interbody device checked once again and these were acceptable.There were no patient complications.On (b)(6) 2005, the patient was discharged from the hospital.On (b)(6) 2009, the patient underwent a ct scan of the chest with intravenous contrast due to neoplasm of retroperitoneum.Impression: questionable 0.24-cm nodular density in the lateral right upper lobe in image 42, series 7.Advise followup in three months.Nonspecific fatty right axillary lymph node.Probable early minimal coronary calcification.Unremarkable study otherwise.Also, the patient underwent a ct scan of the abdomen and pelvis with oral and intravenous contrast due to neoplasm of retroperitoneum.Impression: 5.4-cm enhancing mass in the inferior right hepatic lobe margin likely metastasis.Post left nephrectomy.No lymphadenopathy.Slightly enlarged prostate.Probable bone islands in the left iliac bone at l2 near the s1 joint on the left.The iliac bone shows low attenuation or lucent area with marginal sclerosis that might relate to cyst versus osteolytic metastasis with therapeutic response.Correlation with bone scan and pet scan might be useful.Left pedicle screw fixation at l5-s1.On (b)(6) 2009, the patient underwent mri of the abdomen with and without contrast due to leiomyosarcoma of the retroperitoneum with resection of the left kidney and status post radiation treatment.Impression: there was a large contrast enhancing mass seen in the inferior tip of the right lobe of the liver which measures 6.7 x 4.8 x 5 cm.This was worrisome for a large metastatic lesion.There was a smaller 1 cm area of increased enhancement also seen in the inferior aspect of the right lobe of the liver.This may represent a small second metastasis versus extension of the larger mass.There was susceptibility artifact consistent with retroperitoneal dissection seen in the left renal bed and the left kidney has been removed.There was no evidence for residual or recurrent mass seen in the left renal fossa.There was mild s-shaped scoliosis.Otherwise, unremarkable mri of the abdomen.Also, the patient underwent mri scan of the pelvis with and without contrast due to due to leiomyosarcoma of the retroperitoneum with resection of the left kidney and status post radiation treatment.Impression: the prostate gland measures 5.3 x 3.3 cm.There was mild heterogeneity of the prostate gland.Recommend clinical correlation and evaluation with psa.2.There was a 1.5 x 0.9 cm lesion seen involving the left iliac bone adjacent to the sacroiliac joint.This was somewhat heterogeneous in signal with predominant decreased signal on both t1 and t2 weighted images.This could represent an early metastasis.Recommend clinical correlation and consider pet scan versus bone scan for further evaluation.Otherwise unremarkable mri of the pelvis.On (b)(6) 2010, the patient underwent ct scan of the abdomen and pelvis with oral and intravenous contrast due to leiomyosarcoma of the left kidney.Impression: inferior right hepatic lobe mass again noted approximately 4.6 cm maximal diameter, smaller compared to previous suggestive of improvement of metastasis.Post left nephrectomy without tumor recurrence in the surgical site.No lymphadenopathy.Slightly enlarged prostate, unchanged.Probable bone islands in the left iliac bone and at l2 unchanged.Defect with sclerotic margins in the left iliac bone near the s1 joint unchanged probably osteolytic metastasis with therapeutic response.Unchanged left l5-sl pedicle screw fixation with a vertical strut.Mild sigmoid diverticulosis.Also, the patient underwent a ct scan of the chest with intravenous contrast due to leiomyosarcoma of the left kidney.Impression: no pulmonary nodules identified at this time.Prior questionable nodule in the right upper lobe lateral aspect was not identified at this time.Unchanged fatty axillary lymph nodes were again noted.These were probably benign.Unremarkable study otherwise.No evidence for metastasis or new masses.Also, the patient underwent a ct scan of the neck with the intravenous contrast due to leiomyosarcoma of the left kidney.Impression: mild inferior mucosal thickening of the bilateral maxillary antra suggesting chronic sinusitis.Nonspecific bilateral submandibular and jugular lymph nodes.Pet scan might be useful.No suspicious mass or skeletal metastasis.Also, the patient underwent mri of the abdomen due to leiomyosarcoma of the left kidney and retro peritoneum post-left nephrectomy.Impression: heterogeneously enhancing mass in the posterior inferior right lobe of the liver consistent with metastatic disease.This was stable in size and contour since the prior mri.Negative for adenopathy.Post-left nephrectomy.Bone island of l2 and post-pedicle screw fixation at l5-s1, unchanged.Also, the patient underwent mri of the pelvis with and without contrast due to leiomyosarcoma of the left kidney and retro peritoneum post-left nephrectomy.Impression: mild prostate hypertrophy with normal signal intensity, unchanged.Bilateral small inguinal hernias containing fat, unchanged.Negative for adenopathy.Enhancing lesion in the left ilium, unchanged, most consistent with metastatic disease.Sclerosis of the right ilium and bone island of l2, unchanged.Postsurgical changes from left pedicle screw fixation at l5-s1 with desiccation of the l5-s1 disc, unchanged.Probable hemangioma of l4, unchanged.On (b)(6) 2010, the patient underwent a whole body pet/ct scan due to sarcoma.Impression: no suspicious uptake seen.Status post left nephrectomy.Focal activity in the right 10th rib laterally attributed to healing rib fracture.On (b)(6) 2010, the patient underwent a ct scan of the abdomen and pelvis without and with iv contrast due to leiomyosarcoma of the left kidney and post-left nephrectomy.Impression: negative for adenopathy.Post-left nephrectomy.No residual or recurrent tumor was seen.Simple cyst of the spleen, unchanged.Mild prostate hypertrophy, unchanged.Left intrapedicular screw fixation at l5-s1 with associated degenerative disc disease and right facet hypertrophy, unchanged.Mixed lytic sclerotic lesion of the posterior left iliac crest and lytic lesions of l4 and l5, unchanged.These correspond to pet/ct findings, suspicious for metastatic disease.Bone island of l2, unchanged.Left inguinal hernia containing fat, unchanged.Also, the patient underwent ct scan of the chest without and with iv contrast due to leiomyosarcoma of the left kidney and post-left nephrectomy.Impression: negative for adenopathy.Atheromatous changes of the aorta.Coronary artery calcification.Discoid atelectasis in the lingula, unchanged.Generalized osteopenia and mild dextroscoliosis at t8-9, unchanged.Also, the patient underwent ct scan of the neck without and with iv contrast due to leiomyosarcoma of the left kidney and post-left nephrectomy.Impression: bilateral chronic maxillary sinusitis, unchanged.Nonspecific bilateral submandibular, jugular and posterior triangle nodes, not significantly changed.Moderate degenerative disc disease at c5-6, unchanged.Also, the patient underwent whole body pet/ct scan due to sarcoma.Impression: stable whole-body pet/ct scan in comparison to (b)(6) 2010.Status post left nephrectomy.On (b)(6) 2011, the patient underwent a ct scan of the chest due to renal cancer and post left nephrectomy.Impression: negative for adenopathy.Atheromatous changes of the aorta and coronary artery calcification, unchanged.Stable discoid atelectasis of the lingula.Generalized osteopenia and mild dextroscoliosis at t8-t9 unchanged.Also, the patient underwent ct scan of neck with contrast due to renal cancer and post left nephrectomy.Impression: stable right ethmoid and maxillary sinusitis.Moderate degenerative disc disease at c5-c6, unchanged.Negative for adenopathy.Also, the patient underwent a ct scan of the abdomen and pelvis without and with oral and intravenous contrast due to renal cancer and post left nephrectomy.Impression: post left nephrectomy.Negative for adenopathy.Prostate hypertrophy, unchanged.Post intrapedicular screw fixation at l5-s1 with degenerative disc disease at this level unchanged.Stable lytic lesions of l4 and was most consistent with hemangiomata and mixed lytic sclerotic lesion of left ilium unchanged, suggestive of hemangioma versus metastatic disease.Bone scan was suggested for follow-up.Stable bone island of l2.On (b)(6) 2011, the patient underwent whole body pet/ct scan due to history of sarcoma, status- post nephrectomy.Impression: the sclerotic and lytic lesion of the left iliac bone has decreased in metabolic activity and was now isometabolic.This may be postsurgical.Postoperative changes sacrum and lower lumbar spine.Status-post left nephrectomy stable.The metabolic activity in the right foot was probably secondary to inflammation due to arthritis.On (b)(6) 2011, the patient underwent ct scan of the pelvis with contrast due to renal carcinoma.Impression: stable ct scan of the pelvis.No interval change since prior study dated (b)(6) 2011.Also, the patient underwent a ct scan of the abdomen without and with contrast due to renal carcinoma.Impression: stable ct scan of the abdomen.No interval change since prior study dated (b)(6) 2011.No definite evidence for metastatic disease.Status post left-sided nephrectomy.Small bone island at l2 and postoperative changes in the lower lumbar spine.Also, the patient underwent ct scan of neck with contrast due to renal carcinoma.Impression: there was mild enlargement of the right and left lobes of the thyroid gland and a small probable cyst in the isthmus of the thyroid gland on the right side measuring 4 mm in size.Thyroid ultrasound may be helpful for better evaluation.The rest of the neck was unchanged since prior study dated (b)(6) 2011 with no definite evidence of metastatic disease.There were small nodes adjacent to the submandibular glands.There was fatty replacement involving the parotid and submandibular glands bilaterally.Also, the patient underwent a ct scan of the chest with contrast due to renal carcinoma.Impression: stable ct scan of the chest.No interval change since prior study dated (b)(6) 2011.No definite evidence of metastatic disease.On (b)(6) 2011, the patient underwent a whole body pet/ct scan due to sarcoma of the kidney.Impression: left nephrectomy without evidence of tumor recurrence in the left renal fossa.Lucent lesion with sclerotic border of the left ilium most likely a benign lesion.On (b)(6) 2012, the patient underwent ct scan of neck with intravenous contrast with indication of restaging retroperitoneal sarcoma.Impression: no evidence of metastatic disease or pathologic lymphadenopathy in the neck.Mild chronic maxillary sinus disease.Also, the patient underwent a ct scan of the abdomen without and with contrast and ct scan of the pelvis with contrast with indication of restaging retroperitoneal sarcoma.Impression: no evidence of local tumor recurrence or definite metastatic disease in the abdomen or pelvis.Indeterminate hepatic lesion, for which further evaluation with mri or attention at follow-up was recommended.Probable post radiation induced changes in the lumbar spine.Please correlate clinically.Also, the patient underwent a ct scan of the chest with contrast with indication of restaging retroperitoneal sarcoma.Impression: no evidence of metastatic disease or pathologic lymphadenopathy in the chest.On (b)(6) 2012, the patient underwent whole body pet/ct scan due to history of sarcoma of the left kidney with left nephrectomy.Impression: left nephrectomy without evidence of tumor recurrence in the left renal fossa 2.Lucent lesion with sclerotic border of the left ilium most likely a benign lesion.On (b)(6) 2012, the patient underwent ct scan of neck with iv contrast with indication of left-sided nephrectomy for tumor.Impression: small lymph nodes especially adjacent to the submandibular gland and to a less extent in the posterior triangles of the neck.Mild enlargement of the thyroid gland and small hypodensity in the right lobe.Inflammatory changes in the right maxillary sinus.Stable ct scan of the neck, no interval change since previous study dated (b)(6) 2012, no definite evidence of metastatic disease.Also, the patient underwent a ct scan of the pelvis with contrast with indication of left-sided nephrectomy for tumor.Impression: stable ct scan of the pelvis, no interval change since previous study dated (b)(6) 2012.Mild enlargement of the prostate gland.Postoperative changes involving l5 and s1 on the left side and probable benign sclerotic density in the left iliac bone adjacent to the sacroiliac joint.The patient also underwent a ct scan of the abdomen without and with contrast with indication of left-sided nephrectomy for tumor.Impression: there was a small hypodensity in the right lobe of the liver posteriorly adjacent to the hepatorenal fossa with some enhancement seen best on mri scan suggestive of hemangioma please correlate with liver function tests.Status post left-sided nephrectomy with no evidence of recurrent mass.Small hiatal hernia.Otherwise, negative ct scan of the abdomen with and without intravenous contrast.The patient also underwent ct scan of the chest with iv contrast with indication of left-sided nephrectomy for tumor.Impression: stable ct scan of the chest, no interval change since previous study dated (b)(6) 2012, no definite evidence for metastatic disease.The patient also underwent mri of the pelvis without and with contrast due to history of left retroperitoneal sarcoma.Impression: mild enlargement of the prostate gland.Probable benign lesion in the left iliac bone adjacent to the left sacroiliac joint.Postoperative changes involving l5 and s1 on the left side.Areas of focal fatty deposition or vertebral body hemangiomata involving the l4 vertebral body, right iliac bone, and right acetabulum.Also, the patient underwent mri of the abdomen without and with contrast due to history of left retroperitoneal sarcoma.Impression: status post left-sided nephrectomy with no evidence of recurrent mass.T2 hyperintensity in the right lobe of the liver adjacent to the hepatorenal fossa suggestive of hemangioma please correlate with liver function tests.Small hiatal hernia otherwise, negative mri scan of the abdomen with and without intravenous contrast.Also, the patient underwent whole body pet/ct scan due to sarcoma, left kidney for evaluation.Impression: essentially stable exam.Post-surgical changes compatible with left nephrectomy without evidence of tumor recurrence.Mild prominence of tracer uptake in the bone marrow similar to prior exam, which could represent underlying physiologic process, anemia, or related to residual post-treatment changes from chemotherapy administration.Clinical correlation was recommended.On (b)(6) 2013, the patient underwent a ct scan of neck with iv contrast with indications of leiomyosarcoma of the left kidney.Impressions: nonspecific submental node, unchanged.Marked degenerative disk disease and mild spondylosis at c5-c6, unchanged.Decreasing right maxillary and ethmoid sinusitis with stable left maxillary sinusitis.The patient also underwent a ct scan of the abdomen with and without contrast and ct scan of pelvis with contrast with indications of leiomyosarcoma of the left kidney.Impression: post left nephrectomy.Negative for adenopathy.Probable emangioma of the posterior right lobe of the liver, unchanged.Prostate hypertrophy.Post laminectomy and left intrapedicular screw fixation at l5-s1, unchanged.Left iliac bone defect, unchanged possibly consistent with postsurgical change.Probable bone island of l2, unchanged.The patient also underwent a ct scan of the chest with iv contrast with indications of leiomyosarcoma of the left kidney.Impression: nonspecific right hilar node, decreased since the prior study.New discoid atelectasis in the lingula.No acute cardiopulmonary disease.On (b)(6) 2013, the patient underwent mri of the pelvis without and with contrast due to history of retroperitoneal sarcoma.Impression: stable mri scan of the pelvis.No interval change since the previous study dated (b)(6) 2012.Postoperative changes at l5 and s1 on the left side.Slightly enlarged prostate gland and thick-walled bladder otherwise, negative mri scan of the pelvis with and without intravenous contrast.Also, the patient underwent mri of the abdomen without and with contrast due to history of retroperitoneal sarcoma.Impression: stable mri scan of the abdomen.No interval change since the previous study dated (b)(6) 2012.Status post left-sided nephrectomy.Small area of abnormal signal intensity and enhancement in the right lobe of the liver adjacent to the hepatorenal fossa, possibly representing a hemangioma.Please correlate with liver function tests.Small area of diminished t1 and increased t2 weighted signal intensity in the spleen, unchanged.Small hiatal hernia.Otherwise, negative mri scan of the abdomen with and without intravenous contrast.Also, the patient underwent whole body pet/ct scan due to history of sarcoma involving the left kidney with left nephrectomy.Impression:there was no abnormal area of hypermetabolic activity suggestive of neoplasm.Left level 1-b and right level ii subcentimeter minimally metabolic cervical neck lymph nodes were most likely inflammatory.Left nephrectomy with no abnormal activity or mass noted in the left renal fossa.On (b)(6) 2013, the patient underwent a mri of the abdomen without and with contrast due to history of retroperitoneal sarcoma status post resection and history of left nephrectomy.Impression: stable appearance of the peripherally enhancing lesion in the inferior right hepatic lobe, most likely representing a hemangioma.Tiny cyst in the anterosuperior aspect of the spleen was also unchanged.No evidence of mesenteric or retroperitoneal adenopathy.No significant interval change compared to the prior study.Also, the patient underwent mri of the pelvis without and with contrast due to history of retroperitoneal sarcoma status post resection and history of left nephrectomy.Impression: prostatomegaly.No evidence of metastatic lymphadenopathy.Postsurgical changes in the lower lumbar spine.On (b)(6) 2013, the patient underwent pet/ct scan of whole body due to sarcoma, left kidney.Impression: prior left nephrectomy without evidence of local tumor recurrence.No discrete abnormal tracer uptake noted elsewhere otherwise to suggest metastatic disease.Mildly fdg-avid bilateral level i and ii lymph nodes remain, likely representing ongoing inflammatory/infectious process.Similarly, accentuation of tracer uptake within the palatine tonsils.
 
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 Key5046302
MDR Text Key24788831
Report Number1030489-2015-02150
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 08/03/2015
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 NumberM115001AAI
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/01/2015
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;
-
-