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

Catalog Number 7510200

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

Patient Problems Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Stenosis (2263); Shaking/Tremors (2515); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient presented with the following pre-operative diagnoses of lytic spondylolisthesis, l5-s1; bilateral l5 foraminal stenosis; right greater than left leg pain.The patient underwent the following procedures: anterior spinal fusion, l5-s1; anterior competitor cage with rhbmp-2/acs; posterior instrumentation, l5-s1 with danek; posterior foraminotomy, l5 foramen.Per the op notes, the surgeon packed two sponges with rhbmp-2acs into the cage and just gently tamped it to proper position.Competitor plate and bone screws were also implanted during the surgery.No patient complications were noted.On (b)(6) 2011: the patient presented with pain in the right leg below knee in one spot.Diagnosis: lumbar radiculopathy.The patient discontinued percocet tablets.On (b)(6) 2011: the patient presented for a follow-up visit.Patient reported that the pain has decreased but still significant and needs ¿ihss¿ for housework and ¿hhrn<(>&<)>pt.¿ diagnoses: erectile dysfunction, stenosis, lumbar spine, w/neurological signs, adjustment disorder with depressed mood.On (b)(6) 2011: the patient underwent physical therapy and as the goals were met, he discontinued it on (b)(6) 2011.On (b)(6) 2011: the patient called in to the doctor and stated that he is taking valium.The doctor notified him that he doesn¿t need to take flexeril if he is taking valium and discontinued morphine tablets to patient.On (b)(6) 2011: the patient presented with various pains, spasms, and aches in the right leg.The surgeon reviewed ct scan which shows the screws and cage in acceptable position.No evidence of nerve impingement.On (b)(6) 2011: the patient presented for a follow-up visit.The patient reported that he is walking better with pain control.Diagnoses: erectile dysfunction, stenosis, lumbar spine, w/neurological signs, adjustment disorder with depressed mood.The patient started using morphine.On (b)(6) 2011: the patient presented for a follow-up visit.Diagnosis: rhinitis.On (b)(6) 2011: the patient presented with back pain greater than right leg pain.Diagnosis: chronic low back pain.The patient will extend work disability.On (b)(6) 2011: the patient presented with chronic low back pain.The patient¿s medication neurontin was increased to ¿tid.¿ on (b)(6) 2012: the patient called in to the doctor and complained of right thigh tremors intermittent and it was worse when lying down with the right knee bent with foot planted on the bed.Diagnoses: lumbar radiculopathy, tremor.On (b)(6) 2012: the patient presented with leg pain for the follow-up visit.He also complained of ¿gerd¿ symptoms.Diagnoses: lumbar radiculopathy, ¿gerd¿, chronic low back pain, erectile dysfunction.On (b)(6) 2012: the patient called in to the doctor and stated that he is feeling worse after taking medication.He also reported that omeprazole is not helping.On (b)(6) 2012: the patient complained of nausea in morning and he feels glassy and bloated.He tried prilosec, but there was no relief.Diagnosis: dyspepsia.On (b)(6) 2012: the patient presented for a follow-up visit.Diagnoses: lumbar radiculopathy, health check up adult.On (b)(6) 2012: the patient¿s medication morphine was increased to 60mg and the patient preferred mallinckrodt brand of percocet - watson not as effective.On (b)(6) 2013: the patient presented for a follow up visit.Diagnoses: lumbar radiculopathy, health check up adult, chronic low back pain.

Manufacturer Narrative

Concomitant product: depuy cage, depuy plate and bone screws, posterior instrumentation (implant (b)(6) 2011).On (b)(6).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/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: 4245455
• MDR Text Key: 5048562
• Report Number: 1030489-2014-04352
• 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: 10/13/2014

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
• Device Expiration Date: 02/01/2014
• Device Catalogue Number: 7510200
• Device Lot Number: M111064AAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2014
• Initial Date FDA Received: 11/12/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2011
• 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