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 Wound Dehiscence (1154); Unspecified Infection (1930); Neuropathy (1983); Pain (1994); Staphylococcus Aureus (2058); Seroma (2069); Stenosis (2263); Anxiety (2328); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

(b)(4) (wound site complicaitons); (b)(4) (persisting back pain); (b)(4) (fluid collection); (b)(4) (revision surgery).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.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) 2010: the patient was pre-operatively diagnosed with: degenerative disc disease particularly at l2-l3, l3-l4 and l4-l5; lumbar spondylosis, l2-l3, l3-l4 and l4-l5; worsening significant lower back pain and left lower extremity radiculopathy; history of the job back injury and underwent the following procedures: bilateral lumbar laminectomy, l2-l3, l3-l4 and l4-l5 with bilateral medial facetectomies and bilateral total radical discectomies for neural decompression at l2-l3, l3-l4 and l4-l5 bilaterally; posterior lumbar inter body fusion, l2-l3, l3-l4 and l4-l5 using python inter body peek cages packed with morselized autograft and cancellous allograft bone chips; bilateral posterolateral fusion from l2-l5 utilizing rhbmp-2/acs along with morselized autograft from the same skin incision; harvesting of morselized autograft from the same skin incision for posterolateral fusion purposes partucularly l2-l3, l3-l4 and l4-l5 bilaterally; bilateral pedicle screw placement with segmental fixation from l2-l5 using pedicle screw instrumentation system along with crosslink placement at l3-l4 as well; a 360 degree fusion of the lumbar spine through the same skin incision posteriorly which involves inter body fusion and posterolateral fusion all done through the same skin incision posteriorly at l2-l3, l3-l4 and l4-l5; intraoperative bilateral lower extremity emg monitoring, somatosensory evoked potential monitoring and eeg monitoring; intraoperative ap and lateral fluoroscopy for placement of lumbar instrumentation and level loca lization.As per op-notes" i opened to large kits of rhbmp-2/acs and these were allowed to set up on the back table.I used one large kit on each side for posterolateral fusion.I did not use any bone rhbmp-2/acs inside the cages though, that were lateral placed for the inter body fusion.I then performed and interbody fusion posteriorly using basically a transforaminal interbody fusion cage which was peek cage called python.This was a 12 x 28 mm cage packed with morselized autograft and cancellous allograft bone chips along with demineralised bone matrix.A posterior lumbar interbody fusion was performed at each level using the single large peek cage which was a sort of banana curvilinear cage placed in the disc space uneventfully.On (b)(6) 2010: the patient presented with chief complaint of excruciating postoperative back pain, right hip and buttock pain.On (b)(6) 2010: the patient was pre-operatively diagnosed with: status post posterior lumbar fusion from l2-l5; history of on the job back injury several months ago; severe worsening lower back pain and right lower extremity radiculopathy; recurrent lumbar foraminal narrowing on the right l2-l3, l3-l4 and l4-l5; large postoperative lumbar sub fascial fluid collection and underwent the following procedures: exploration of posterior lumbar fusion from l2-l5 bilaterally; evacuation of large sub fascial posterior lumbar seroma; redo laminectomy on the right at l2-l3, l3-l4 and l4-l5 for neural decompression; use of intraoperative lateral fluoroscopy for level localization; exploration of posterior lumbar wound.On (b)(6) 2011: the patient presented for follow up visit due to persistent and worsening pain.Impression: lumbar wound infection versus seroma; failed back surgery syndrome; status post hardware removal one month ago; status post l2-l5 fusion; chronic opioid use.The patient was pre-operatively diagnosed with: lumbar wound infection; failed back surgery syndrome; status post lumbosacral hardware removal; remote l2-l5 instrumented fusion; nicotinism; chronic opioid use; anxiety and underwent the following procedures: lumbar wound incision and drainage; wound closure over drains.On (b)(6) 2011: the patient presented with severe low back pain with wound infection and wound dehiscence partially.The patient was pre-operatively diagnosed with: chronic non-healing lumbar wound posteriorly at l3-l4; failed back surgery syndrome; severe persistent lower back pain; history of lumbar fusion from l2 to l5 with hardware removed; history of lumbar infection and hardware removal with staph aureus.History of on the job back injury and underwent the following procedures: incision and drainage of posterior lumbar wound particularly at l3-l4; complex closure of lumbar wound posterior l3-l4.

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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5871175
• MDR Text Key: 51926770
• Report Number: 1030489-2016-02341
• 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,Followup
• Report Date: 07/18/2016

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: 07/18/2016
• Initial Date FDA Received: 08/12/2016
• Supplement Dates Manufacturer Received: 07/18/2016
• Supplement Dates FDA Received: 09/24/2017
• 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): Other