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); Pain (1994); Scarring (2061); Numbness (2415)

Event Type  Injury  

Event Description

It was reported that the patient presented with a history of low back pain and lower extremity pain, numbness and weakness refractory to conservative treatment.Imaging studies and a lumbar disco gram revealed degenerative disk disease at the l4-5, l5-sl level.Patient underwent posterior lumbar interbody fusion.Postoperatively, the patient did well.She did have some problems with severe pain and did require increases in various pain medications.Patient was deemed stable and discharged home.264 days post-op: patient complained of severe low back pain which is similar to the type of pain she had experienced before surgery.Her pain is mostly to her low back, although she does have lower extremity pain, numbness, and weakness.697 days post-op: patient complained of low back pain as sharp, burning, shooting, stabbing, gnawing and aching.Patient reports that the pain score at best is 10/10, at worst is 10/10 and currently is 10/10.Pain is aggravated by sitting and standing.Pain gets better by walking.The pain interferes with daily activities.711 days post-op: patient diagnosed with low back pain and lumbar radiculopathy.Patient treated with epidural injection.777 days post-op: patient seen for follow up visit status post caudal epidural injection.Pain is aggravated by daily activities and walking.Pain gets better by medication and rest.She has numbness in her bilateral lower extremities.805 days post-op: patient seen for follow up.Patient reports generalized body pain.833 days post-op: patient continues to complain of low back pain on a daily basis.She states that this time she is most bothered by burning pain in her hips bilaterally with radiation down the right lower extremity to her foot.Patient treated with epidural injection ten days later.851 days post-op: patient is seen today for a follow-up visit with the chief complaint of low back pain radiating into bilateral legs.881 days post-op: patient is seen for a follow-up visit with the chief complaint of low back pain.Patient continues to complain of neck and low back pain on a daily basis.She states her leg pain is very bothersome particularly at night.1088 days post-op: patient seen for follow up.Complained of episode last week during which she bent forward and then could not straighten.She states she feel that she has bulges at surgical site since that time w/ increased low back pain (lbp).Musculoskeletal comments: there is vertebral tenderness at all lumbar levels.There is spinal tenderness throughout as well.Surgical hardware is not distinctly palpated.There is soft tissue inhornogenaity along surgical incision consistent w/ scarring.This is focally tender.1116 days post-op: patient seen for follow up.Patient continues to complain of intermittent episodes of numbness in both upper and lower extremities.1560 days post-op: patient seen for follow up.Patient reports severe exacerbation of llb pain w/ radiation to buttock and lle to calf.She also reports n/t in feet she states she still has neck pain but lumbar issues are most bothersome.Since the last visit, the initial pain has deteriorated.The patient had a spinal cord stimulation trial in october 2010 which did not work.She has had multiple steroid injections.

Manufacturer Narrative

(b)(4).Neither the device nor applicable imaging study films 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 and/or used 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.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4238766
• MDR Text Key: 22163707
• Report Number: 1030489-2014-04290
• 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: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2014
• 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
• Date Manufacturer Received: 10/09/2014
• 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