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

Catalog Number 7510200

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

Patient Problems Edema (1820); Neuropathy (1983); Loss of Range of Motion (2032); Inadequate Pain Relief (2388); 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 spine fusion surgery from vertebrae l5-s1 wherein rhbmp-2/acs was implanted.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space).Post-op, the patient complained of increasing low back pain, with associated radiculopathy in her lower extremities.The patient continued to experience lower back pain, with pain radiating to her hips and legs, and edema in her legs.Patient could not sit, stand, or walk for extended periods of time, and patient had limited mobility.

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

The patient presented with following pre-op diagnosis: intractable low back pain, degenerative disc disease at l5-s1 and lumbar disc disease.The patient underwent following procedures: anterior lumbar discectomy, fusion, placement of implants and plate.As per operative notes,¿ the end plates were curetted and dilators placed so we were able to place an 11 mm implant.After the implants had been curetted bone graft was prepared and placed within the 11 mm spacer implant and then impacted into the disc space.The distractor was removed.A 37 mm plate was then placed.Four 22 by 5.0 locking screws were then placed through the plate under fluoroscopic guidance.Additional bmp was packed under the plate and then the peritoneum and wound closed in routine fashion.Sterile bulky dressing was applied.¿ no intra-operative complications were reported.

• 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: 5562371
• MDR Text Key: 42144671
• Report Number: 1030489-2016-01027
• 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510200
• Device Lot Number: M112003ABG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/28/2018
• 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