MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Fatigue (1849); Hematoma (1884); Nausea (1970); Neuropathy (1983); Swelling (2091); Vomiting (2144); Weakness (2145)

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

It was reported that on per medical records (b)(6) 2006: the patient presented with the chief complaint of stenosis.And underwent l5-4 decompression fusion.(b)(6) 2006: the patient presented with pre-operative diagnosis of l4-5 grade ii spondylolisthesis and underwent bilateral l4-5 intertransverse process fusion with iliac crest bone graft, pedicle screws, demineralized bone matrix and bmp, bilateral two level insertion of pedicle screws at l4 and l5 , harvest of iliac crest bone graft from the left posterior superior iliac spine through a separate incision.Perop notes: dissection was carried out to expose the transverse process at l4-s as well as, the facet joint at l4-s.Once this done 6.25 x 45 mm screws were placed in the pedicles at l4 and l5, this was done under c-arm control in both the ap and lateral planes as well as, direct vision.A 1 /4 inch rod was then fashioned to fit between the two screws.A mild amount of distraction was carried out.This seemed to reduce the l4 vertebra.Prior to placing the screws a through decortication was done of the facet joints.And the transverse processes at l4-5.The dbm, which had been mixed with some of the blood from the bone graft site was then placed into the intertransverse process area.This was followed by the bmp and finally by the cancellous bone graft.Attention was then turned to the right hand side, in a similar manner a posterolateral approach was done on that side.The transverse processes and facet joints were identified.The same size screws were placed on the right hand side.Again, prior to placing the screws, the area had been thoroughly decorticated down to bleeding bone.The dbm was ,then placed into the intertransverse process areas followed by the bmp and cancellous bone graft.A final check was done on the c-arm.The rods and screws appear to be in good position.There was good reduction of the l4 vertebra.The area was then closed with #1 vicryl.Subcutaneous tissues were reapproximated with 2-0 vicryl.Skin was closed with staples.The graft site was closed in a similar manner.(b)(6) 2007: the patient presented with chief complaint of urinary frequency and underwent renal/retroperitoneal us.Impression: normal study.No definite stone within either kidney.No hydroncphrosis.(b)(6) 2007: the patient presented with the chief complaint of total vaginal hysterectomy and underwent vaginal hysterectomy procedure.The patient presented with pre-operative diagnosis of symptomatic fibroids and underwent vaginal hysterectomy.Admission impression: abnormal uterine bleeding in a patient with fibroids and known anemia, probably secondary to menorrhagia.Also, the patient has dyspareunia.(b)(6) 2007: the patient presented with chief complaint of abdominal pain.(b)(6) 2007: the patient presented with pelvis abscesses, heavy periods and dysmenorrhea.Impression: the patient has a hb of 7.7 and in s/p surgery.The patient is symptomatic and extreme fatigue.The patient would benefit from iv iron as well as a blood transformation now have explained the risks and benefits of epogen and blood transfusion.The patient understands the risks of anaphylascis and increased risk of thrombosis, msk pain, ha, niv fever and chills.The patient understands these risks and wishes to proceed.(b)(6) 2007: the patient presented with chest pain and nausea.(b)(6) 2007: the patient presented for follow-up visit.(b)(6) 2007: the patient presented with chief complains of pelvic mass, nausea and vomiting.The patient underwent physical examination: impressions: this is a (b)(6) gravida 3, para 3 female status post hysterectomy who presents with nausea and vomiting as well as a persistent pelvic masses.On previous ct scan, these masses are consistent with either an abscess or an infected hematoma.During a previous hospitalization, the patient received iv iron as well as a two unit transfusion.(b)(6) 2007: the patient presented for pinc-hematology.(b)(6) 2007: the patient presented with chief complaint of continued nausea and vomiting, low-grade fever and left-sided abdominal pain.(b)(6) 2007: the patient underwent ct scan.The patient presented with weakness, nausea and lower abdominal pain.(b)(6) 2007: the patient had infected hematoma.(b)(6) 2007: the patient underwent ct showed decreases size of hematoma.(b)(6) 2005, (b)(6) 2007: the patient presented for follow-up visit.(b)(6) 2008: the patient presented with swelling and leg pain.(b)(6) 2008: the patient presented for follow up visit.(b)(6) 2009: the patient presented with chronic low back pain, s/p l4-5 fusion w/ new radiculopathy symptoms.And underwent mri lumbar spine without and with contrast.Impression: fusion with pedicle screws at the l4 and l5 levels without acute abnormality or evidence of complication.(b)(6) 2009: the patient presented with back pain.Impression: mild degenerative changes in the lumbar spine as noted above.(b)(6) 2009: the patient underwent ct guided l4-5 esi.(b)(6) 2009: the patient underwent ct-guided spinal epidural steroid injection.(b)(6) 2013: the patient presented with bilateral heel spurs and bilateral knee pain.(b)(6) 2013: the patient underwent lumbar esi.(b)(6) 2013: the patient underwent mri lumbar spine without contrast.Impression: stable postsurgical changes from posterior spinal fusion at l4 and l5 with near-anatomic alignment and no evidence of complication.Probable moderate right neural foraminal narrowing at l5-s1.Please note, this level is partially obscured by the adjacent susceptibility artifact from surgical hardware.(b)(6) 2013: the patient presented with pain ho haeel spurs and underwent foot 3 views-r.Impression: moderate hallux valgus.Early osteoarthrosis first metatarsophalangeal joint.The patient presented with worsening back and right leg pain and underwent l-spine 4 views.Impression: stable grade i spondylolisthesis ls posterior l4, disc space narrowing l5-s i probably secondary to degenerative disc disease.(b)(6) 2013: the patient underwent ct guided lumbar esi.(b)(6) 2013: the patient presented with back pain and underwent ir neuro procedure.Impression: selective ct guided right l5 nerve root block.

• 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 Key: 5079836
• MDR Text Key: 25933929
• Report Number: 1030489-2015-02383
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• 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

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510400
• Device Lot Number: M115007AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2015
• 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 Number: 1
• Patient Outcome(s): Other
• Patient Weight: 86