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 Neuropathy (1983); Pain (1994); Numbness (2415)

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.

Event Description

It was reported that on: (b)(6) 2013, the patient was pre-operatively diagnosed with adult idiopathic flat back syndrome status post posterior scoliosis fusion many years ago down to l4.Lumbar spinal stenosis and distal degeneration l4 to the sacrum status post extension of instrumentation and fusion to the sacrum and ilium with interbody fusion at l4-5.3.Two year postoperative bilateral implant failure l5-s1 with suspected pseudarthrosis and underwent the following procedures: segmental spinal instrumentation removal consisting of 3 rods, multiple screws, 1 crosslink, t12-sacrum and ilium, 6 instrumentation levels removed.Fusion and exploration to confirm pseudarthrosis at l5-s1 and slight motion also noted at l4-l5.Posterior interbody fusion l5-s1 with autogenous bone and 6 mg of bone morphogenetic protein (bmp) on acs.Anterior structural titanium cage x1 at l5-s1.Revision bilateral iliac screws for sacropelvic fixation.Revision posterior spinal fusion l4, l5, s1.Revision segmental spinal instrumentation in the form of bilateral rods, pedicle screws, crosslinks, t12-sacrum and ilium, 6 revision instrumentation levels.Posterior spinal fusion with autogenous local bone and 48 mg of bmp on 4 graft matrix sponges.As per the operative notes: "autogenous bone and one bmp-soaked sponge was placed in front of the cage,one sponge inside the cage was tapped into position, distraction was released and everything was secure.Screws were placed at l4, l3 and l2 and l4, l3, l2 and l1 on the right side.All free bony prominences were decorticated between l4 and s1 and autogenous local bone was placed as well as 4 sponges, 1 on each side soaked with bmp.Plenty of bone graft was there for the fusion.¿ post-op, the patient suffered progressively worsening pain in her lower back with radiculopathy and numbness from her left hip down her left leg.The patient had difficulty walking and her injuries prevented her from practicing daily life activities.The patient suffered serious and permanent injuries.

• 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: 6892942
• MDR Text Key: 87296032
• Report Number: 1030489-2017-02104
• 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: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2015
• Device Catalogue Number: 7510800
• Device Lot Number: M111202AAF (X4)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/17/2013
• 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
• Patient Age: 58 YR