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

Catalog Number 7510600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Unspecified Infection (1930); Weakness (2145); Numbness (2415)

Event Type  Injury  

Event Description

It was reported that the patient underwent a fusion procedure at l4 to s1 using rhbmp-2/acs on (b)(6) 2008.Patient's post-operative period was marked by increasingly severe pain in her lower back radiating down her lower left extremity.On (b)(6) 2010, patient underwent a surgery after a deep spine infection at her surgical site.Patient's hardware from previous fusion was removed, and her infection was irrigated and drained.A subsequent lumbar mri, performed on (b)(6) 2012, revealed osteophytic ridging compressing her spine at the surgical site.Currently, patient continues to experience severe and unrelenting low back pain, lower left extremity weakness and numbness, and left-sided drop foot.

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.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2008 the patient underwent: l4 bilateral laminectomies with foraminotomies, right partial medial facetectomy and left complete inferior facetectomy.L5 bilateral laminectomies with foraminotomies, right partial medial facetectomy and left complete inferior facetectomy.Transforaminal interbody lumbar fusion, l4-5.Transforaminal interbody lumbar fusion, l5-s1.Peek interbody fusion cage, l4-5.Peek interbody fusion cage, l5-s1.Posterior spinal fusion, l4-5.Posterior spinal fusion, ls-s1.Posterior segmental spinal instrumentation with 3dx screw/rod construct, l4 through s1.Morcellized autograft bone graft.Morcellized allograft bone graft.Bone morphogenic protein sponge preparation and application.Preoperative diagnosis: multilevel spinal stenosis with spondylolisthesis.Per-op notes: the severe stenosis was decompressed in this manner.After the decompression was completed, the left transforaminal approach was performed to the interbody spaces at l4-5 and l5-s1.The end plates were debrided down to healthy bone and all the disk material was removed.A large rhbmp-2/acs set was mixed and all six sponges were rolled and inserted into the fully cleaned and prepared interspace, three sponges at l4-5 and three sponges at l5-s1.Next, peek interbody fusion cages were filled with morcellized autograft.Per medwatch report # mw5058083, it was reported that on an unknown date in 2008, the patient underwent 3-level plif involving three large rhbmp-2/acs bone graft kits used in combination with three spacers.Post-op, on (b)(6) 2008, it was reported that the patient developed bmp-induced bony overgrowth and the patient allegedly sustained unspecified 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3963523
• MDR Text Key: 4608058
• Report Number: 1030489-2014-03326
• 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
• Report Date: 12/14/2015

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
• Device Expiration Date: 03/01/2010
• Device Catalogue Number: 7510600
• Device Lot Number: M110610AAJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2014
• Initial Date FDA Received: 07/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2007
• 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; Required Intervention