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 Headache (1880); Neuropathy (1983); Pain (1994); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented with the following pre-op diagnosis: status post posterior instrumented fusion with first -generation cd implants t4-l4.Status post anterior single screw, single rod fusion t10-l4.Surgeries 16-17 years ago for scoliosis.Nonunion at l3-l4.Subsequent severe disc degeneration at l3-l4, l4-l5 and l5-s1, with mild coronal and sagittal imbalance.The patient underwent the following procedures: application of halo and halo traction, partial removal of the first-generation cd instrumentation posteriorly, revision posterior segmental spinal instrumentation from t11 to the sacrum and pelvis bilaterally, posterolateral spinal fusion l3-l4, l4-l5 and l5-s1, 35 ml local bone graft, 25 cc fresh frozen femoral head/allopac, 120 mg bmp on 60 ml crm sponges, somatosensory potential monitoring, percutaneous motor-evoked potential monitoring.As per op-notes, ¿i then placed the bone graft mixture.The 60 ml crm sponge soaked with 120 mg bmp.The procedure was 50% or so harder than a standard procedure because of the scar tissue we had to dissect off from l3 to the sacrum and somewhat more difficult to get our fixation points, because a lot of the fixation points were in the fusion mass.So both the fusion procedure and the instrumentation procedure were 50% harder than a primary case.On the left side, we placed 5 screws.On the right side we placed 6 screws.As stated, the instrumentation was t11 to the sacrum and pelvis, and the fusion was l3-l4, l4-l5, l5-s1, and the 3 degenerated segments at the bottom.¿ the patient underwent first stage of surgery, which was posterolateral lumbar fusion on the lumbar region of her spine from vertebrae l3 to s1.Reportedly, rhbmp-2/acs was used in this surgery.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage (posterolateral elements).Post-op, the patient experienced increasing severe low back and hip pain.She continues to experience chronic pain in her lower back, radiating pain into her hips, generalized pain throughout her whole body, headaches, and numbness in her mid-back and feet.She must constantly change positions due to pain and requires occasional use of a wheelchair to assist in ambulation.

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7464894
• MDR Text Key: 106624542
• Report Number: 1030489-2018-00604
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843829
• UDI-Public: 00681490843829
• 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: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2010
• Device Catalogue Number: 7510800
• Device Lot Number: M110709AAJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2008
• 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