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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Stenosis (2263)

Event Type  Injury  

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.

Event Description

It was reported that on, (b)(6) 2011: patient presented with severe adjacent level degeneration with spinal stenosis and instability at l3-l4 above the previous l4-l5 fusion.Procedure: hardware removal l4-l5; inspection of fusion found to be reasonably solid; l3-l4 posterior lateral spinal fusion; l3-l4 posterior instrumentation; left tlif procedure at l3-l4; titanium cage 13 x 30 millimeters, titanium; partial smith-peterson osteotomy on the right for lordosis at l3-l4; extension of instrumentation to l4-l5 with reinforcement of the fusion.An mri revealed he had developed severe adjacent level degeneration at l4-l5 with severe stenosis and very soft tissue hypertrophy of the ligamentum flavum and facet capsules, etc.Per-op notes: once this was done, surgeon placed 3 milliliters of autograft and 1 milliliters of rhbmp-2/acs anteriorly and then a 13 x 30 millimeter titanium cage was filled with autograft and a milliliter of rhbmp-2/acs, tapped into the disc space from left to right and then rotated around and tapped anteriorly 2 centimeters above the annulotomy.Ap and lateral x-ray showed that the lordosis had been increased 8 degrees, that the cage was in good position and the screws were in good position.The patient was removed from the table having tolerated the procedure well.On (b)(6) 2014: patient presented with severe adjacent level degeneration with spinal stenosis at l2-l3 above her previous l3-l5 fusion.Post-op diagnosis: multiple fragments of herniated disc at l2-l3 further narrowing the canal.Procedure: hardware removal at l3, l4 and l5; explore posterior spinal fusion at l3, l4, and l5, found to be solid; extend the posterior spinal fusion at l2-l3; re-instrument 4.75 titanium from l2 to l3; left tlif procedure; cage 12 x 36 millimeters, titanium; local bone graft combined with allograft combined with a large bmp kit.Per-op notes: simultaneous to this, the autograft that was obtained from the fusion area and also from the decompression was tubularized in along with some allograft in a bmp sponge, large kit 12 milligrams.The patient was removed from the table having tolerated the procedure well.

• 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: 5437620
• MDR Text Key: 38224718
• Report Number: 1030489-2016-00483
• 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: 01/26/2016

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?: No
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/16/2016
• 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