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

Catalog Number 7510800

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

Patient Problems Neuropathy (1983); Discomfort (2330); Sleep Dysfunction (2517)

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) 2006: the patient presented with pre-op diagnosis: grade i spondylolisthesis at l5-s1.Grade ii isthmic spondylolisthesis at l5-s1.Procedures performed: l5 laminectomy with bilateral l5 foraminotomies.L4 to the sacrum, posterolateral fusion.L5-s1 posterior lumbar interbody fusion.Insertion of intervebral cages at l5-s1.Posterior segmental instrumentation of l4 to the sacrum.Left posterior iliac crest bone graft harvest, morcellised autologous.Insertion of epidural catheter for postoperative analgesia.(b)(6) 2006: the patient presented with pre-op diagnosis: grade ii isthmic spondylolisthesis at l5-s1.Procedures performed: l5 laminectomy with bilateral l5 foraminotomies.L4 to the sacrum, posterolateral fusion.L5-s1 posterior lumbar interbody fusion.Insertion of intervebral cages at l5-s1.Posterior segmental instrumentation of l4 to the sacrum.Left posterior iliac crest bone graft harvest, morcellised autologous.Insertion of epidural catheter for postoperative analgesia.Per-op: l5 laminectomy was performed and bilateral l5 foraminotomies performed.Excellent decompression of the nerve roots was achieved at s1.L5 had some element of continued compression due to prominence of the l5-s1 disk, and this was excised bilaterally as were osteophytes bilaterally about the disk space.Next on the right, subtotal facetectomy was performed.Disk space was entered at l5-s1 and all disk material was excavated.Parallel channels were prepared with osteotomes for cage insertion.Then under mild distractive force, two appropriate size cages were packed with rhbmp-2/acs bone morphogenic protein impacted into position followed by additional bone and morcellized graft.Next, attention was redirected to the midline.The lateral elements of l4-5 and s1 were decorticated and bone grafted bilaterally with positive rhbmp-2/acs in iliac graft.Pedicles of l4-5 and s1 were broached, sounded for integrity, measured, packed with powdered gelfoam and then appropriate size screws inserted, fastened to an appropriate length of rod under mild compressive force.Epidural catheter was inserted using loss-of-resistance technique on the left side.The patient was discharged on (b)(6) 2006.(b)(6) 2006: the patient presented for follow up of sleep pattern disturbance / insomnia, situational depression, agitation / anxiety, and chronic back pain following lumbar surgery.(b)(6) 2006: the patient presented with persisting back pain and persisting/worsening burning, tingling, dysesthesias involving primarily the left lower extremity and primarily the lateral aspect.(b)(6) 2006: the patient presented with lower extremity pain and paresthesias.(b)(6) 2006: the patient presented for follow up.(b)(6) 2007: the patient presented for follow up of persistent back pain, lower extremity neuropathy.(b)(6) 2007: the patient presented for follow up of persistent back pain, lower extremity neuropathy bilateral, depression, insomnia, breast pain.(b)(6) 2007: the patient presented with right-sided throat discomfort, right ear discomfort, cough productive of yellowish sputum.(b)(6) 2007: the patient presented with persisting/ unchanged low back pain involving both lower extremities, once again, left greater than right.The patient underwent ct of lumbar spine following myelography.There was progressing fusion across ls-s1 disk space.There was no abnormality involving the nerve root sleeves.(b)(6) 2007: the patient presented with persisting/ unchanged low back pain involving both lower extremities, once again, left greater than right.(b)(6) 2007, (b)(6) 2006: the patient presented for follow up of bilateral low back pain, persisting lower extremity pain, questionably neuropathic, and persisting depression with anxiety.(b)(6) 2007: the patient presented with persisting dyesthesias and low back pain.(b)(6) 2007: the patient presented for a follow up of depression, anxiety, insomnia, persisting radicular low back pain, polyneuropathy, b12 deficiency.

• 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: 5180514
• MDR Text Key: 29410782
• Report Number: 1030489-2015-02811
• 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

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2008
• Device Catalogue Number: 7510800
• Device Lot Number: M115008AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2015
• 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