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); Inflammation (1932); Neurological Deficit/Dysfunction (1982); Pain (1994); Injury (2348); Ambulation Difficulties (2544); No Code Available (3191); Cancer (3262)

Event Type  Injury  

Event Description

It was reported that the patient presented to the operating room for lumbar fusion surgery at l5-s1.The doctor performed a removal of hardware, exploration of fusion and repair of pseudoarthrosis at l5-s1 with left iliac crest bone graft, rhbmp-2/acs, and segmental pedicle screw fixation at l5-s1 using pedicle screw spinal system.Bmp was used during the posterolateral fusion.The bmp was placed along the transverse processes.Sometime post-op, the patient was seen for follow up.Reportedly, the patient presented with increasing back pain and radiating pain to his leg, nerve injury, severe back pain and bony overgrowth.Approximately nine years post-op, the patient underwent surgery to remove the bone overgrowth.Reportedly, the patient had experienced ectopic bone growth, inflammatory reaction, non-union, cancer, neuro deficit, nerve injury, and neurological injury, immobility, pain and mental anguish.

Manufacturer Narrative

Concomitant medical products: pedicle screw instrumentation (implant (b)(6)/2004; explant unk).(b)(4).Neither the device nor applicable imaging study films or patient medical records 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/used 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) 2004 the patient underwent: removal of hardware, exploration of fusion and repair of pseudoarthrosis at l5-s1 with left iliac crest bone graft, rhbmp-2/acs and with segmental pedicle screw fixation at l5-s1 using pedicle screw system.Preoperative diagnosis: possible pseudoarthrosis, l5-s1.Per-op notes: ¿once the hardware was removed, the fusion mass was thoroughly evaluated.All of the scar tissue was removed from the bone so we could clearly see the facet joint at l5-s1 and the transverse process at l5¿ the transverse processes were thoroughly decorticated prior to placement of the screws.A 3cm x 5.5cm rod was used to connect to the 2 screws and all of the set screws were tightened.We thoroughly decorticated the transverse processes of l5 and the sacral ala and we placed a 3cm x 5.5cm rod with connectors attached to the pedicle screws.At that point, we obtained ap and lateral permanent radiographs to confirm position.We then harvested bone graft from the left posterior superior iliac spine.We used a large rhbmp-2/acs package and used the collagen matrix to wrap around cancellous bone graft.We then placed the rhbmp-2/acs and cancellous bone graft in to the lateral gutters in direct contact with the decorticated transverse processes of l5 and sacral ala.We then observed the wound to make sure that there was no significant bleeding and then began closing.¿ on (b)(6) 2013 the patient underwent: removal pseudoarthrosis with bilateral l5-s1 medial facetectomies.The patient was status post l5-s1 instrument fusion in the past with bmp.He has had bone overgrowth and heterotopic ossification formation from the bone graft used at the l5-s1 for posterolateral fusion impinging in making a pseudoarthrosis with the inferior articular processes of l4 and lamina of l4.Because of that he had pain with extension.He has failed conservative treatment.He had temporary relief from injections in this pseudo articulation.Because of this, he was presented for the above surgery in hopes to decrease his symptoms.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4270080
• MDR Text Key: 20066125
• Report Number: 1030489-2014-04504
• 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: 04/18/2016

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: 10/23/2014
• Initial Date FDA Received: 11/21/2014
• Supplement Dates Manufacturer Received: Not provided; 04/18/2016
• Supplement Dates FDA Received: 05/11/2016; 09/21/2017
• 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