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 Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2007, the patient underwent spine fusion surgery on the thoracic and lumbar region at levels t4-s1.The patient was implanted with rhbmp-2 collagen sponge which was applied from posterior approach.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine and was placed outside a cage (i.E.In the posterolateral gutters).Post-op, the patient complained of progressively worsening low back pain with radiculopathy in her lower extremities, due to which patient underwent for 4 revision surgeries.The patient underwent spine fusion surgery on the thoracic and lumbar regions at levels t12-s1.The patient was implanted with rhbmp-2 collagen sponge to the thoracic spine which was applied from posterolateral approach.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine and was placed outside a cage (i.E.In the posterolateral gutters).

Manufacturer Narrative

(b)(4): neither the device nor applicable medical records or imaging studies were returned nor provided for evaluation.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2008: patient presented with pre-op diagnoses: nonunion, flat back deformity, spinal stenosis.Procedure: removal of segmental spinal instrumentation.Exploration of fusion, spinal segmental instrumentation t4-s1.Bilateral iliac fixation.T12-s1 bilateral posterolateral fusion with local autogenous bone, 2 large kits, bmp and 10 cc of bone graft matrix.Per operative notes: two large kits of bmp and 10 cc of bone graft matrix were placed.No other information was provided.

Manufacturer Narrative

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

• 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: 4861009
• MDR Text Key: 5851054
• Report Number: 1030489-2015-01261
• 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,Followup,Followup
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• 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: 03/11/2016
• 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