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 Syncope (1610); Neuropathy (1983); Injury (2348); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that on (b)(6) 2002, the patient presented for followup with complaints of chest pain.On (b)(6) 2005, the patient presented for followup with complaints of back pain, left lower extremity pain and numbness and weakness.On (b)(6) 2005, the patient underwent a surgery with diagnosis of mechanical low back pain secondary to degenerative disc disease at l4-5 evel radiating into both lower extremities.Operation performed: 360 degree single incision lumbar fusion at l4- 5 level.Decompressive lumbar laminectomy at l4 and l5 levels.Decompression of the thecal sac and the nerve roots bilaterally.Partial medial facetectomy at l4-5 level bilaterally.Interbody fusion at l4-l5 level using a threaded titanium cage packed with rh-bmp2/acs, using fluoroscopic guidance.Pedicle screw fusion at l4 and l5level using fluoroscopic guidance lateral mass fusion at l4 - ls level using autologous bone chips mixed with all graft bone chips.Per op-notes, using the nerve root retractor, the thecal sac and the nerve root were retracted medially and the l4-l5 disc was exposed.Using a 15 blade, cruciate incision was made into the disc space and discectomy was performed at the l4-l5 level.Under fluoroscopic guidance, interbody cage packed with rh-bmp2/acs was placed into the disc space at l4-l5 level and l4-l5 interbody fusion was accomplished.Next using fluoroscopic guidance, 6.5 mm by 45 mm pedicle screws were placed into the pedicles of both l4 and l5 bilaterally.Heads of the pedicle screws were connected by a 5.5 mm titanium rod.The rod was seemed to the heads of the pedicle screws by tightening the set screws to the appropriate torque.A cross link was placed, connecting the rods.Next lateral mass fusion was accomplished using autologous bone graft mixed with allograft bone chips and bone putty.Ap and lateral x-rays were obtained to check the placement of the hardware again and hardware was noted to be in good position.No patient complications.On (b)(6) 2005, the patient was admitted when she was presented to the emergency room with an episode of syncope and drop attack.On (b)(6) 2005, the patient was discharged.On (b)(6) 2005, the patient presented for followup for post-op check and sutures removal.On (b)(6) 2005, the patient presented for followup with complaints of aches and pains.The patient's ap and lateral xrays of the lumbar spine which revealed good placement of hardware.On (b)(6) 2005, the patient presented for followup with complaint of pain in her left buttock area and right thigh as she fell down a flight of stairs at home.On (b)(6) 2006, the patient underwent a procedure of lumbar epidural steroid injection with diagnosis of post laminectomy pain syndrome and lumbar radiculopathy.On (b)(6) 2008, the patient presented for followup with diagnosis of left vocal cord polyp, evidence of reflux.On examination with fiberoptic laryngoscopy, there was evidence of left vocal cord polyp and posterior commissure thickening consistent with reflux laryngitis.On (b)(6) 2008, the patient underwent a procedure of micro direct laryngoscopy and excision of left vocal cord lesion with diagnosis of left vocal cord polyp and reflux laryngitis.On (b)(6) 2011, the patient underwent a mri of cervical spine without contrast due to bilateral hard numbness in the 4th and 5th fingers.Impression: there has been enlargement of central disc osteophyte complex at c5-6 that results in mild canal stenosis.No significant foraminal stenosis.No abnormal cord signal intensity.On (b)(6) 2011, the patient presented for followup with complaints of lateral pain in her neck radiating down the left upper extremity with associated tingling and numbness in the left pinky and ring fingers.The patient underwent a mri of the cervical spine that revealed evidence of mild to moderate disc bulge at c56 level on left side.On (b)(6) 2011, the patient underwent an mri of left brachial plexus without and with contrast due to nerve damage.Impression: there are some cystic changes seen in both glenoids but i am not seeing any pathology involving the brachial plexus.On (b)(6) 2011, the patient presented for followup for review of mri of the brachial plexus.On (b)(6) 2011, the patient presented for evaluation.Impression: chronic cervicalgia with evidence of mild spinal stenosis and disk osteophyte complex at c5-c6 resulting in some diskogenic and europathic pain generators.Gastroesophageal reflux disease.Hyperlipidemia.Tobacco abuse.The patient also underwent a procedure of cervical epidural steroid injection under c-arm fluoroscopy with diagnosis of chronic cervicalgia with evidence of mild spinal stenosis and disk osteophyte complex at c5-c6 resulting in diskogenic and neuropathic pain generators.On (b)(6) 2011, the patient underwent a procedure of cervical epidural steroid injection under c-arm furoscopy with diagnosis of chronic cervicalgia with evidence of mild spinal stenosis and disk osteophyte complex at c5-c6 resulting in diskogenic and neuropathic pain generators.No patient complications.On (b)(6) 2011, the patient underwent qsgr exam of lumbosacral spine in ap and lateral views due to increased back pain.Impression: stable alignment with no fracture seen.Stable appearance of the hardware in the lower lumbar spine.On (b)(6) 2011, the patient presented for followup with complaint of low back pain radiating down both lower extremities.On (b)(6) 2011, the patient underwent a mri of lumbar spine without and with contrast due to low back pain.Impression: pedicle fusion at l4-5 level with maintained vertebral alignment.A small broad-based disk protrusion in the right central and right lateral location at l3-4 level, minimally compromising the right lateral recess and may compromise the right l4 nerve root.On (b)(6) 2011, the patient presented for followup with complaint of back pain radiating down the left lower extremity, with associated burning sensation.The patient underwent a mri of lumbar spine that revealed evidence if post-operative changes at the l4-5 level with pedicle screws.On (b)(6) 2011, the patient underwent an electro diagnostic examination.Impressions: today's electro diagnostic evaluation did yield some abnormalities.Emg produces abnormal motor units within the myotomal distributions of l2-4 on the right and l2-5 on the left.These findings are consistent with chronic radiculopathy.The process could not be isolated to a single root which may implicate each or any of the aforementioned levels.Spontaneous potentials limited to the left paraspinals but due to their isolated distribution, cannot be relied upon as a solitary indicator of active denervation due to prior spinal surgery.On (b)(6) 2011, the patient presented with medical problems of failed back syndrome with chronic bilateral lumbar radiculopathy, history of chronic cervicalgia with evidence of mild spinal stenosis and disk osteophyte complex at c5-c6 resulting in discogenic and neuropathic pain generators, gastroesophageal reflux disease, hyperlipidemia.The patient underwent a physical examination.Impression: failed back syndrome with chronic bilateral lumbar radiculopathy and with emg evidence of chronic radiculopathy in both extremities.Tobacco abuse.Gastroesophageal reflux disease.Hyperlipidemia.

• 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: 5055425
• MDR Text Key: 24999934
• Report Number: 1030489-2015-02207
• 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
• Report Date: 08/11/2015

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: Not provided
• Initial Date FDA Received: 09/04/2015
• 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