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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Ossification (1428); Irritation (1941); Muscle Spasm(s) (1966); Neurological Deficit/Dysfunction (1982); Weakness (2145); Tingling (2171); Injury (2348); Numbness (2415)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2010, the patient underwent for orthopedic spine fusion surgery in which surgeon utilized rhbmp-2/acs and bone graft material in the following mentioned three locations: in the cage device mounted in place for a transforaminal lumbar interbody fusion at l3-4; anteriorly in the disc space at l2-3; and wrapped around allograft placed posteriorly for posterior spinal fusion as well as the remainder of the local autograft that was harvested.Surgeon used posterior approach to place the rhbmp-2/acs bone graft into the lumbar region of patient's spine in order to fuse vertebrae.Post-op, on an unknown date, patient reported that her symptoms returned which included intractable back pain, weakness, neurological deficit, systemic inflammatory response, bilateral thigh numbness, nerve pain, spasm, tingling, pain, hypersensitivity and inflammation throughout her body in all of her joints that continued to grow worse and bmp migration from the implant site to other areas of the body ossifying connective tissue creating osteophytes in unintended locations resulting from exuberant bone growth caused by the use of rhbmp-2/acs which as patient reported, she still continues to suffer.Allegedly the patient suffered from severe bodily injuries, significant inflammation throughout her body in all of her joints symptoms of reflex sympathetic dystrophy, nerve root irritation, and reactive inflammatory process secondary to the material implanted during surgery.Patient is still suffering from continuous pain in her back and legs from everyday activities.Patient also alleged of sustaining severe and permanent injuries.

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.

• 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: 4930828
• MDR Text Key: 6052312
• Report Number: 1030489-2015-01552
• 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: Other
• Type of Report: Initial
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2015
• 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