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

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

Patient Problem Weight Changes (2607)

Event Type  Injury  

Event Description

It was reported that in early 2010, the patient was experiencing intermittent back pain.In (b)(6) 2010, the patient visited the surgeon for back pain due to scoliosis.On (b)(6) 2010, the patient underwent posterior spinal instrumentation, posterior spinal fusion and allograft on spine.Post-op, the patient felt there was a knot protruding from the incision site in lower back.This was a "loose screw".Approx.Six weeks following the surgery, the patient had an infection in the back due to swimming in a creek.On (b)(6) 2010, the patient underwent second surgery to replace loose screw from first surgery.Shortly after surgery, the patient complained of a new pain in her right shoulder blade that was intense and constant.The patient continued to follow-up, at each visit of constant pain, difficulty bending over, and an inability to lift heavy objects.The patient continued to follow up and inform of increased pain until (b)(6) of 2013.The patient was implanted with rhbmp-2/acs.Since, the patient underwent surgery the pain was much more frequent and was limited in walking, sitting, and was unable to play soccer.The patient had lost a significant amount of weight and had experienced brittle hair and hair loss.

Manufacturer Narrative

(b)(4).Date of implant is unknown but the surgery happened in october 2010.Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

• 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: 4962396
• MDR Text Key: 6255600
• Report Number: 1030489-2015-01873
• 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
• Report Date: 07/06/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 08/03/2015
• 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