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 Ossification (1428); Abdominal Pain (1685); Headache (1880); Incontinence (1928); Nausea (1970); Neuropathy (1983); Pain (1994); Swelling (2091); Vomiting (2144); Weakness (2145); Stenosis (2263); Injury (2348); Obstruction/Occlusion (2422); Neck Pain (2433); Disc Impingement (2655)

Event Type  Injury  

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.

Event Description

It was reported that on (b)(6) 2010 ¿ pt.With pseudoarthrosis and spondylolisthesis, l5-s1 underwent surgery for posterior exploration spinal fusion, foraminotomy, laminectomy l5-s1, partial l4, bilateral pedicle screw instrumentation with arthrodesis and reduction of spondylolisthesis partial l4 to s1, posterolateral intertransverse arthrodesis l4-s1.Anterior transabdominal exposure of spine for exploration of fusion, removal of anterior instrumentation, partial anterior corpectomy, anterior reconstructive surgery with intervertebral device l5-s1.Rhbmp-2 mixed with local bone was placed over the transverse processes of l5-s1.Rhbmp-2 with corticocancellous bone chips and bone graft was placed over the lateral spinal gutters.For the anterior procedure, rhbmp-2, autograft, and allograft were placed in a 22mm lordotic cage.On (b)(6) 2010 ¿ pt.Presents for follow-up.The pain which improved after surgery is again exacerbating.There is persistent left l5 sensory symptom.On (b)(6) 2010 ¿ lumbar ct shows ¿satisfactory interval placement of anterior and posterior fusion devices traversing l4, l5, and s1, bi lateral laminectomies and anterior fusion by means of instrumentation at the level of l5-s1.No complications are evident.There is now 12mm of anterolisthesis of l5 upon s1.On (b)(6) 2011 ¿ pt.Presents for follow-up and reports having difficulty holding her urine and bowel in the past 7 months.On exam, hypoalgesia is noted in the perianal and perivulvar-inguinal region.Surgeon notes ¿she may have cauda equine syndrome related to her back.¿ on (b)(6) 2011 ¿ mri shows ¿there may be some mild anterior displacement of the cages with depression of the upper anterior aspect of s1.I cannot identify any instability of the hardware.There is a grade ii l5-s1 spondylolisthesis.There is apparent stenosis of the neuroforamina at l5-s1 but no significant stenosis of the canal is suggested.Above l5 there are no significant findings.Further assessment of the hardware l5 suggested, perhaps with a combination of plain film imaging and ct scanning.¿ on (b)(6) 2011 ¿ pt.Presents for follow-up with pain in the lower back and extremities, and diffuse arthralgias over the upper back.On (b)(6) 2012 ¿ pt.Presents for neurological follow-up with left leg pain and weakness greater than the right.The patient also reported neck pain, dizziness, and headaches, and radicular pain into the upper extremities.Cervical mri shows herniated disc at c4-5.Review of lumbar mri and ct scan showed stable findings and no findings to indicate a need for further surgical treatment.Dr.Recommends a spinal cord stimulator for trial due to chronic pain symptoms.On (b)(6) 2012 ¿ pt.Presented for procedure to treat small bowel obstruction.¿the first point of obstruction was at the small bowel, w as pinned down and plastered to her l5-s1 junction which had a previous fusion and there was a hardware plate inserted.This caused a kink in the bowel and a high-grade partial obstruction in this spot which dilated the bowel proximally, such that the bowel then became trapped underneath an adhesion causing the complete bowel obstruction.The segment of the small bowel that was stuck down onto the orthopedic hardware was removed.On (b)(6) 2012 ¿ ct of abdomen/pelvis.On (b)(6) 2012 ¿ pt.Follow-up after laparotomy for small bowel obstruction.On (b)(6) 2012 ¿ ct of abdomen/pelvis.On (b)(6) 2012 ¿ pt.Office visit.Patient alleges ¿the material they used during her back surgery had caused some ectopic bone growth that grew into/around her intestine.¿ on (b)(6) 2012 ¿ pt.Follow-up visit.Pt.Has been approved for temp dorsal column stimulator.On (b)(6) 2012 ¿ pt.Follow-up visit notes mri of lumbar spine ¿showed a grade 3 spondylolisthesis for foraminal narrowing at the l5-s1 level impinging on the l5 nerve roots bilaterally.¿ ¿degenerative disc disease of the cervical spine with myelopathy.¿ on (b)(6) 2012 ¿ pt.Presents to the er with constipation.Diagnosed with gerd.Following the procedure, the patient continued to suffer from severe back pain, swelling and nerve pain.In (b)(6) 2012, the patient presented to the emergency room with increased abdominal pain, nausea and vomiting.After undergoing diagnostic testing, the patient underwent corrective surgery for a complete small bowel obstruction.During this procedure, it was noted her small bowel was stuck to the orthopedic hardware, or the ocelot cage/bmp device.The patient remained in the icu and on an ng tube for several days.The patient continues to suffer severe pain and constant nausea, and underwent significant rehabilitation after the surgery.The patient reportedly has never recovered from her surgery and she continues to have daily severe disabling pain that prevents her from performing many basic activities of daily living.Reportedly the patient suffered injuries and damages, including but not limited to, corrective surgery, chronic pain, and neural impingement.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6046519
• MDR Text Key: 58046027
• Report Number: 1030489-2016-02956
• 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,Followup
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2012
• Device Catalogue Number: 7510400
• Device Lot Number: M110806AAJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2010
• 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: 55