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

Catalog Number 7510400

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

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

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.Multiple products 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.

Event Description

It was reported that on (b)(6) 2007, surgeon performed spine fusion surgery using rhbmp-2 on the lumbar region of her spine from vertebrae l5 to s1.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space, lateral gutters and facet joint).Post-op, patient reportedly had increasing low back pain, with radiating pain into her hips, buttocks and legs.Patient continues to experience chronic lower back pain, with pain radiating to her hips, pelvis and legs, muscle spasms in her lower back.Patient experiences difficulty sitting, standing and walking, and requires use of a cane, wheelchair and walker for assistance in ambulation.

Manufacturer Narrative

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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was pre-operatively diagnosed with degenerative disc disease with decision for anterior/posterior spinal fusion, anterior fusion l5-s1 spinal level and underwent the following procedure: anterior retroperitoneal exposure l5-s1, anterior spinal fusion.The patient was pre-operatively diagnosed with l5-s1 post laminectomy degenerative disc disease and underwent the following procedure: stage i anterior spinal fusion with total discectomy l5-s1 using femoral cortical ring allograft combined with bone morphogenic protein, anterior instrumentation using a plate.As per op-notes,¿ under distraction we measured the disc space and then obtained appropriate sized femoral cortical ring allograft.It was custom shaped into a wedge based upon the dimensions of the disc space under distraction.Once we had custom fashioned the femoral cortical ring allograft, it was packed with bone morphogenic protein-soaked sponge in the posterior disc space after which we then placed the structural graft using an insertion device.Once the structural graft was properly positioned, the insertion device was removed.We had excellent fit and fill of our structural graft.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: 6025077
• MDR Text Key: 57250365
• Report Number: 1030489-2016-02871
• 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,Followup
• Report Date: 12/29/2017

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: 12/01/2009
• Device Catalogue Number: 7510400
• Device Lot Number: M110609AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: 09/19/2016; 12/11/2017
• Supplement Dates FDA Received: 09/26/2017; 12/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2007
• 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