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 Necrosis (1971); Pain (1994); Seroma (2069); Stenosis (2263); Meningitis (2389); Post Operative Wound Infection (2446)

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.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) 2009, the patient presented with pre-op diagnosis of: congenital kyphoscoliosis with severe sagittal imbalance; multiple prior surgeries with retained instrumentation; spinal stenosis.The patient underwent following procedure: removal of spinal instrumentation; fusion mass exploration; l1-l5 bilateral laminectomies with foraminotomies and partial medial facetectomies; transpedicular bilateral partial corpectomy l4 and wedge resection of the vertebral body; dural repair under loupe magnification; posterior spinal fusion t11-s1; posterior segmental spinal instrumentation t11-s1 with screw rod construct; spinopelvic fixation with right iliac screw; morselized autograft bone graft; bmp sponge preparation and application; somatosensory evoked potential spinal cord monitoring.Per op-note, ¿.Two large bmp sets were mixed , all 12 sponges were placed posteriorly for the arthrodesis t11-s1, and all of the morsellized autograft bone graft available from the multilevel laminectomies and from the partial corpectomy at l4 were all saved , all of this autograft bone was placed posteriorly and posterolaterally for the arthrodesis t11-s1.¿ the patient had reported necrosis, meningitis, pain, wound infection, seroma and stenosis post-operative.

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: 5655621
• MDR Text Key: 45202790
• Report Number: 1030489-2016-01431
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2011
• Device Catalogue Number: 7510600
• Device Lot Number: M110810AAH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/21/2009
• 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