MAUDE Adverse Event Report: MEDTRONIC INFUSE BONE GRAFT DEVICE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Disability (2371); Cancer (3262)

Event Date 10/05/2012

Event Type  Injury  

Event Description

On (b)(6) 2012, i had a spinal fusion of my 15-sl discs, performed at (b)(6).A medtronic bone graft device and infuse growth hormone was used in the procedure which occurred anteriorly and posteriorly.My pain level increased after surgery resulting in my becoming classified as disabled by (b)(6), and i have been taking prescription pain medication since the surgery.I also was diagnosed with prostate cancer in (b)(6) 2014, and first noticed symptoms of prostate cancer around (b)(6) 2014.I have been in pain and have been forced to decrease my activity level since the surgery, and it has been a very adverse effect on quality of life.

• Brand Name: INFUSE BONE GRAFT DEVICE
• Type of Device: INFUSE BONE GRAFT DEVICE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 5131102
• MDR Text Key: 27782791
• Report Number: MW5056876
• Device Sequence Number: 1
• Product Code: NEK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 57 YR
• Patient Weight: 84