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 Swelling (2091); Weakness (2145); Ambulation Difficulties (2544)

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.

Event Description

It was reported that on (b)(6) 2004, the patient underwent lumbar fusion at levels l4-5 wherein rhbmp-2/acs was implanted.Post-op, the patient had increasing low back pain, and associated radiculopathy in his lower extremities.The patient continued to experience constant and extreme lower back pain, radiating pain to his hips, groin and legs, weakness in his legs, and swelling in his feet.He was unable to sit or stand for extended periods and has difficult walking.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2004, the patient was pre-operatively diagnosed with pseudoarthrosis at l4-5 and underwent the following procedure: l4-5 complete diskectomy with removal of cages and osteotomy of take down of pseudoarthrosis.L4-5 anterior lumbar interbody fusion.Insertion of spacer with rhbmp-2 soaked collagen sponges at l4-5.L4-5 anterior plating.Anterior retroperitoneal exposure of the l4-l5 with mobilization of the iliac vessels, the aorta and vena cava, and also the peritoneal tear.Diskectomy and removal of previously implanted cages (two).Application of femoral bone graft with rhbmp-2 at l4-l5.Fixation of l4-l5 with plate and screws.As per the op notes:¿ the spacer was packed full of rhbmp-2 soaked collagen sponges and then seated in the resection gap under c-arm guidance.The distractor was removed under c-arm guidance.The anterior lumbar plate was applied across the l4-5 interval using 24 mm depth screws.All screws were tightened down so they engaged the locking mechanism on the plate.¿ the patient tolerated the procedure 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5554823
• MDR Text Key: 42076747
• Report Number: 1030489-2016-01002
• 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: 12/01/2017

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 Catalogue Number: 7510400
• Device Lot Number: M112003ABF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: 03/10/2016; 11/06/2017
• Supplement Dates FDA Received: 09/20/2017; 12/01/2017
• 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