MAUDE Adverse Event Report: MEDTRONIC INFUSE BMP

Lot Number M11060LAAG

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 11/01/2006

Event Type  Injury  

Event Description

On (b)(6) 2006, i underwent an anterior/posterior 2 level fusion using medtronic's infuse bmp with multiple cages.I understand the fda approved this device for a single level anterior fusion only.I developed a cdiff infection, retro-grade ejaculation, radiculopathies at the l5/s1 level, severe burning pain throughout my body, permanently disabled and a chronic pain patient for life.

• Brand Name: INFUSE BMP
• Type of Device: INFUSE BMP
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 5347275
• MDR Text Key: 35243411
• Report Number: MW5058896
• 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: 01/03/2016

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: No Information
• Device Expiration Date: 04/01/2009
• Device Lot Number: M11060LAAG
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 52 YR
• Patient Weight: 91