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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Increased Sensitivity (2065); Burning Sensation (2146); Inadequate Pain Relief (2388); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

It was reported that on (b)(6) 2012, patient underwent a l3-l4 anterior lumbar antibody fusion, l4-l5 anterior interbody fusion, an application of intervertebral biomechanical device, globus lordotic peek cage and application of intervertebral biomechanical device at l4-5, globus lordotric peek.Post-operative period was marked by increasingly severe back pain and sensitivity and burning and shooting pains in his legs and feet.It was recommended that patient, undergo a revision surgery.Reportedly, as a result of the use of rhbmp-2/acs in this lumbar fusion surgery, patient still suffers from severe back and leg pain, which prevents him from resuming the activities of his normal life.Patient suffered from abdominal pain causing him to undergo an abdominal surgery.Patient cannot walk or stand for any reasonable period of time because of the pain and must take significant amounts of pain medication.The pain in his legs was so great that he overused his arms and actually torn his rotator cuff.

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: 5551613
• MDR Text Key: 41996073
• Report Number: 1030489-2016-00969
• 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
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2016
• 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