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 Ossification (1428); Seroma (2069)

Event Date 04/10/2015

Event Type  Injury  

Event Description

It was reported in a publication that the authors retrospectively reviewed the charts of 57 consecutive pediatric patients who underwent posterior occipitocervical, cervical, thoracic, lumbar, or lumbosacral spine fusions with rhbmp-2 from (b)(6) 2007, to (b)(6) 2011.The surgery consisted of routine exposure of the spine over the entire length to be instrumented.Placement of segmental instrumentation, if performed, was done in standard fashion.Decortication of the laminae, spinous processes, and facet joints was performed using a matchstick bur after placement of spinal instrumentation.Increments of kits of rhbmp-2 were used in each case and applied on a collagen sponge.The collagen sponges were generally cut into 1-cm strips and placed in a single layer overlying the posterior elements after thorough decortication of the bone.The amount of rhbmp-2 was determined intraoperatively, depending on the surface area of the intended fusion levels.For the purposes of this study, patients and caretaker(s) were brought back to the clinic off schedule for assessment of the development of cancer, or were questioned via telephone follow-up by a clinical neurosurgery nurse.There were no new cases of cancer, or degeneration or metastasis of existing malignancies in this series.Case 1.Female, age 14 yrs, 2 months.Patient presented with a history of lipoblastomatosis, epidural lipomatosis, progressive myelopathy, and spastic paraparesis.Patient underwent decompressive laminectomies at t7-l3 and arthrodesis.36 mg of bmp2, local autograft, and morselized cancellous allograft were used.Post-op, the patient developed sterile seroma, and heterotopic bone formation secondary to bmp with restenosis of spinal canal necessitating reoperation.

Manufacturer Narrative

Article citation: sayama et al.Routine use of recombinant human bone morphogenetic protein¿2 in posterior fusions of the pediatric spine and incidence of cancer.J neurosurg pediatr.2015 apr 10:1-10.Implant: (b)(6) 2007 to (b)(6) 2011.(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.

• 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: anglin greg ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4750460
• MDR Text Key: 21941380
• Report Number: 1030489-2015-00919
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 05/05/2015
• 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
• Patient Age: 00014 YR