MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC INFUSE BONE GRAFT (TITANIUM IMPLANT)

Device Problem Nonstandard Device (1420)

Patient Problems Nerve Damage (1979); Pain (1994); Disability (2371)

Event Date 01/01/2005

Event Type  malfunction  

Event Description

In 2005, patient was implanted with infuse bone graft (titanium implant) manufactured by medtronic.It is designed to infuse a biologic protein called morphogenic bone protein (rhbmph2).This in turn is supposed to stimulate bone growth.He has been in pain since then and the infusion has instead damaged his nerves.He is now unable to do anything because of the disabling effect of the protein.In 2008, it came to light that medtronic admitted having lied to the fda.It is alleged that they had very limited study on people.The issue was heard before a congressional panel and before the senate committee on finance.Medtronic was eventually fined (b)(4).Patient is asking the fda why this device is still in the market despite all these allegations.

• Brand Name: MEDTRONIC INFUSE BONE GRAFT (TITANIUM IMPLANT)
• Type of Device: MEDTRONIC INFUSE BONE GRAFT (TITANIUM IMPLANT)
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4895173
• MDR Text Key: 6831136
• Report Number: MW5043593
• 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: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR