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 Impotence (1925); Muscle Spasm(s) (1966); Paralysis (1997)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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 in medical records that the patient presented at office visit with progressive leg pain.Patient had bilateral numbness going down leg following prior decompression (date unknown).Patient still had persistent numbness and back pain increased along with progressive leg pain over the past year to the point that the patient was having trouble walking.Studies showed that patient had mobile spondylolisthesis at l4-5 and mri interpretation showed that patient profound congenital spinal stenosis still present even after the decompression at l3-4 and l4-5 and somewhat at l2-3.On (b)(6) 2008, the patient underwent myelogram.Shortly after myelogram patient started developing progressively more and more leg weakness bilaterally.Myelogram showed that patient had profound and advanced primary thoracic stenosis in the t10, t11 and t12 area where the spinal canal was basically 4 or 5 millimeters in diameter.Patient was taken to surgery immediately for decompression and fusion.Patient underwent thoracic laminectomy of t10-t12 and lumbar laminectomy, foraminotomy and facetectomy at l2/3 and l3/4 bilaterally, and l4/5 and l5/s1 bilaterally (reoperation of lower two levels).Patient underwent l1 to l5 posterolateral spinal fusion with 6.35 instrumentation (6.5x40 screws and 6.5x45 screws) with x10 crosslinks and t10-t12 posterior spinal fusion with 6.35 instrumentation (5.5 x35 screws) with x10 crosslinks using local bone graft combined with bone graft combined rhbmp-2/acs.Four large kits were used for surgery; 30 milligram dose was placed in the lumbar spine and 10 milligram dose across the lamina in the thoracic.Due to patient's body habitus, prior surgery, extensive scarring, there was a significant loss of normal anatomical structures; much more time involved in dissecting out and identifying the critical structures both decompression and instrumentation wise, and of course, the emergent nature of the procedure and, of course, the congenital abnormalities of severe stenosis all made [surgery] a much higher degree difficult case.No additional complications were noted during surgery.Patient was admitted to hospital for recovery.Over the course of the next several days, patient regained full strength in bilateral lower extremities and had significant improvement in his numbness and tingling in bilateral lower extremities and reported that the sensation in his lower extremities was almost back to normal.He also had improvement in circulation to his lower extremities.Patient was evaluated for physical therapy and neurological consult.At the time of discharge, patient was ambulating in lumbar brace with physical therapy and had 5 out of 5 strength in bilateral lower extremities.On (b)(6) 2008, patient underwent following procedure: 1.1.L1 to l5 posterolateral fusion, 2.L2 to l5 posterior instrumentation 6.35 titanium with x10 crosslinks times 1, 3.T10 to t12 posterior spinal fusion, 4.T10 to t12 posterior instrumentation, 6.35 titanium with x10 crosslink, 5.Local bone graft combined with bone graft combined with 4 large rhbmp-2 kits; for pre-op diagnosis of: 1.Progressive cauda equina syndrome with spinal cord compression due to severe primary thoracic stenosis at t10, 11, 12, 2.Severe spinal stenosis from l2 to l4, 3.Unstable spine l4-5 with mobile spondylolisthesis.Per-op notes: 6.5 x 40 screws were placed at l2 and 45 screws at l3, 4, and 5.This procedure was performed bilaterally.Ap and lateral x-rays showed good position of the screws.Two rods and crosslink was placed which reduced spondylolisthesis by at least 50%.5.5 x 35 screws were placed at t 10, 11, 12.Rods and crosslink were placed and x-rays confirmed their position.Autograft was placed from l2 to l5 between the transverse processes, followed by placement of rhbmp-2 and bone graft.No complications were reported.It was reported that following a posterior lumbar surgery on (b)(6) 2008 using rhbmp-2/acs, the patient allegedly began experiencing increased paralysis, loss of sexual function, loss of feelings in legs and lower body, and muscle spasms.

• 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: 5344582
• MDR Text Key: 35100631
• Report Number: 1030489-2016-00038
• 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: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2015
• 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): Other