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 Abscess (1690); Bacterial Infection (1735); Fever (1858); High Blood Pressure/ Hypertension (1908); Pain (1994); Urinary Tract Infection (2120); Stenosis (2263); Ulcer (2274); Ambulation Difficulties (2544); Hematuria (2558)

Event Type  Injury  

Event Description

It was reported that in 2010 the patient presented with neck and back pain.The patient was scheduled for surgeries.It was reported that the patient underwent lateral lumbar interbody fusion at l1-l2, l2-l3, l4-l5 using rhbmp-2/acs with cages.Following the second surgery, the patient developed a serious infection of the surgical area, e-coli, and abscessed discs.On (b)(6) 2011, patient underwent a laminectomy at l1-l2, l4-l5 and a posterior spinal fusion at t11-l5 using rhbmp-2/acs.The patient continues to experience severe pain, both mental and physical.

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.Products from multiple manufacturers were implanted 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.

Manufacturer Narrative

(b)(4).A.

Event Description

It was reported that on (b)(6) 2011: patient presented for post-operative evaluation.On (b)(6) 2011: patient underwent physical therapy.On (b)(6) 2011: patient presented for follow up of his diabetes.Diagnoses: dm without complication type 2; chronic pancreatitis, anxiety, ddd-cervical, lumbar disc disease.On (b)(6) 2011: patient underwent cervical spine x-ray due to neck pain.Impression: congenital block vertebrae c-c6 level; interfusion and discectomy at c4-c5 and c6-c7 levels.Associated grade 1 c4-c5 spondylolisthesis demonstrating no evidence on instability.On (b)(6) 2011 the patient presented with complaints of low back, pain, scoliosis, ddd.On (b)(6) 2011 the patient presented with the following pre-op diagnosis: severe degenerative lumbar scoliosis: l1-l2, l2-l3, l3-l4, l4-l5; degenerative lumbar spondylolisthesis: l1-l2, l2-l3, l3-l4, l4-l5.The patient underwent the following procedure: stage direct lateral lumbar diskectomy, l1-l2, l2-l3, l3-l4, l4-l5; direct lateral interbody fusion using auto and allograft l1-l2, l2-l3, l3-l4, l4-l5; placement of direct lateral interbody cages l1-l2, l2-l3, l3-l4, l4-l5.Per op notes, at first, using the spinal cord monitoring position of the lumbar plexus was completely determined.The psoas was split and a lateral annulotomy was performed.At this point, the disk was sequentially dilated and the end-plates were prepared for fusion.At this point, the lateral interbody cage was placed in the disc space.Intra-op x-ray was done to check the position of the cage.Under c-arm images, jamshidi needles were placed in the lumbar pedicles at the predetermined levels.Pedicle wires were placed through the jamshidi needles.Then pedicle screws were placed on the wires.Wires were removed then.An appropriate sized rod was placed in a percutaneous fashion in a way that it passed through all of the screws extensions.At this point, the set screws were placed to secure the rod to the screws.The exact same procedure was performed on the opposite side as well.No complications were noted.On (b)(6) 2011 the patient presented with complaints of decreased mobility in adl's status post lumbar spinal fusion.The patient describes the pain as just a deep dull achy pain.Impression: gait disturbance; acute post-op pain.On (b)(6) 2011 the patient came for medical management of diabetes and other comorbidities post-op.Assessment: diabetes mellitus type ii; essential hypertension; degenerative disk disease of cervical region.

• 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: 4119714
• MDR Text Key: 4936337
• Report Number: 1030489-2014-03741
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2013
• Device Catalogue Number: 7510400
• Device Lot Number: M111064AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2011
• 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
• Patient Weight: 86