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

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

Patient Problems Neuropathy (1983); Swelling (2091); Cramp(s) (2193); Dysphasia (2195); Hernia (2240); Injury (2348); Neck Pain (2433)

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 (b)(6) 2004: the patient underwent mri of lumbar spine.Impression: somewhat progressive diffuse disc bulges at l4-5 and l5-s1 with interval development of mild neural foraminal narrowing bilaterally at l5-s1, as compared to previous study.No focal disc herniation is, however, noted.(b)(6) 2005: the patient presented disabled for evaluation of neck, shoulder, arm and hand pain, tingling and numbness, and low back pain.Physical exam showed thin.Spine straight, pelvis level, leg lengths equal.Tender in the low back.Tender in the back of the neck 3/4 of normal neck and back motion.Impression: c6-7 disc herniation and degeneration causing neck and arm symptoms.(b)(6) 2005, (b)(6) 2005: the patient presented for preadmission counselling.(b)(6) 2005: the patient presented with following pre-op diagnosis: marked degenerative disk disease c6-7 with disc osteophyte complex.The patient underwent following procedure: anterior disc excision, decompression, foraminotomy, interbody fusion, c6- 7 with allograft bone wedge and anterior atlantis plate and screws.Intra-op x-rays were taken to confirm positions.No patient complications were reported.(b)(6) 2005, (b)(6) 2005: the patient presented for a follow up of neck pain.X-rays excellent for acdf fusion healing at c6-7.(b)(6) 2005: the patient presented for a follow up of neck pain.(b)(6) 2005: the patient presented with following preoperative diagnosis: painful disc degeneration, disc bulging l4-l5, l5-s1.The patient underwent the following procedure: partial corpectomy and complete disc incision, l4-l5, l5-s1.Anterior interbody fusion l4-l5, l5-s1 with titanium cages and rhbmp-2/acs bmp.Per op note, at l5-s1, after a thorough disc curettage, the cage distract or device was inserted.Reaming was performed under fluoro scopic controls, staying well away from the posterior aspect of the disc space and the foramina.Once this was done, two cages were inserted, 14 x 23 mm, countersunk 4 mm, kept well away from the posterior aspect of the disc space and the foramina.The cages were stuffed with rhbmp-2/acs.Additional rhbmp-2/acs was placed around them followed by anterior dry gelfoam cages at l5-s1 did not protrude anterior or posterior by visualization, palpation, or x-ray.At l4-5, a pair of 14 x 23-mm titanium cages stuffed with rhbmp-2/acs was countersunk 4 mm and under fluoroscopic control was in good position and by visualization and palpation did not protrude anterior or posterior.Additional bits of rhbmp-2/acs were placed about the cages followed by anterior dry gelfoam.The patient underwent x ray of lumbar spine 2 or 3 views.Impression: following anterior discectomy, the disc cages were in satisfactory positions at l4-l5 and l5-s1.(b)(6) 2005: the patient presented status post-surgery, noticed over the last few days cramping behind the left posterior lower thigh and behind the knee and increased pain.(b)(6) 2005: patient presented for re-evaluation.Her lumbar x-rays show cages at 4-5, 5-1.No healing as yet.She may come out of her tlso.(b)(6) 2006: patient presented for re-evaluation.Cervical x-rays show the broken screws with one migrated screw at the c7 level and probable solid fusion healing.The x-rays of the lumbar spine show sentinel signs at 4-5, not at 5-1 yet.(b)(6) 2006: the patient presented for reevaluation.(b)(6) 2006: the patient underwent cervical spine tomography.Impression: failed anterior fusion at the c6-c7 level.Previously introduced bone graft had largely collapsed and there was no bone bridging the former disc space between c6 and c7.There were obvious stress fractures involving both screws through the anterior metallic plate into the body of c7 and of at least one of the screws into c6.(b)(6) 2006: the patient presented for follow up.Recently fell off a dirt bike and scraped her right shoulder.She still had the same pains and clumsiness of her hands she was discussing last visit.Her thoracic mri was negative.Cervical mri showed no sign of any neurocompression.The tomograms of c6-7 showed failed fusion at c6-7 with graft collapse and no bridging bone.In addition, she had the broken hardware.(b)(6) 2006: the patient presented for preadmission counselling.(b)(6) 2006: the patient presented with following pre-op diagnosis: pseudoarthrosis c6-c7 anterior fusion.The patient underwent following procedure: exploration c6-c7 fusion (pseudoarthritic), removal of anterior segmental and broken hardware, partial corpectomy c6-c7 with reexcision of the disc, micro interbody fusion c6-c7 with allograft bone wedge and anterior atlantis plate and screws.No patient complications were reported.(b)(6) 2006: the patient underwent mri of cervical spine due to cervical radiculitis and sciatica.Impression: status post fusion c6-c7.Normal cervical cord.No significant foraminal compromise.The patient also underwent mri of thoracic spine without contrast.Impression: essentially normal mri of the thoracic spine without contrast.Thoracic cord was normal.Mild scoliosis with convexity to the left.(b)(6) 2006, (b)(6) 2006, (b)(6) 2006: the patient presented for reevaluation.(b)(6) 2007: the patient presented for reevaluation.She had been having for many months thoracolumbar pain in the midline which was disturbing to her.She had no deformity.She was tender in the thoracolumbar area.Full neck and back motion.(b)(6) 2007: the patient underwent nuclear medicine exam of bone and/or joint whole body.Impression: mild increased activity in the vertebral body endplates abutting the l4-l5 interspace at which point there had been prior placement of disc cages.(b)(6) 2007, (b)(6) 2007, (b)(6) 2007, (b)(6) 2007, (b)(6) 2008, (b)(6) 2008: the patient presented for follow up.(b)(6) 2007: the patient underwent ct scan of cervical spine.Impression: there was interval change with absorption of the graft at c6-c7 with lack of bony fusion between the c6 and c7 vertebral bodies.In addition the left c6 and both c7 screws were broken in their midportion.They do have components that were embedded within the c6 and c7 vertebral bodies.The anterior plate was slightly offset from the c6 vertebral body by 2.3 mm which was an interval change as well.Alignment however was satisfactory.Acute traumatic lesion was not apparent.(b)(6) 2007: the patient underwent mri lumbar spine with and without contrast.Impression: l4-l5 and l5-s1, discectomies and fusion with metallic intervertebral devices.Anatomic alignment was maintained.Small foci of nonmetallic epidural material were noted within the dorsal aspect of the disc space with no evidence of canal or foraminal stenosis.The patient also underwent mri of the cervical spine without contrast.Impression: oiscectomy and anterior fusion at c6-c7 with maintained alignment.Minimal dorsolateral osteophytes were also noted at this level with no evidence of canal or foraminal stenosis.(b)(6) 2007: the patient presented with injury from mva.She was not knocked unconscious.She developed neck pain, trouble swallowing and new low back pain (b)(6) 2007: the patient presented with difficulty swallowing.The patient underwent a double contrast barium swallow examination.Impression: thickened folds within the distal esophagus which was not felt to represent a hiatal hernia.This may be due to actual esophageal fold thickening or gastroesophageal varices.Further evaluation with direct visualization was recommended.No evidence of esophageal obstruction.

• 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: 5176629
• MDR Text Key: 29218958
• Report Number: 1030489-2015-02788
• 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: 09/28/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 10/25/2015
• 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): Required Intervention
• Patient Weight: 57