MAUDE Adverse Event Report: MEDTRONIC BMP2

Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); Pain (1994); Seroma (2069); Weakness (2145); Stenosis (2263)

Event Date 09/02/2009

Event Type  Injury  

Event Description

Bmp2 grew out of site "ho" causing stenosis lumbar l5-s1 causing pain, weakness, falls, revision surgery due to seromas, need more surgery to repair damage caused by bmp2 by medtronic.

• Brand Name: BMP2
• Type of Device: BMP2
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 3731849
• MDR Text Key: 4327271
• Report Number: MW5035479
• 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: 04/01/2014

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 53 YR
• Patient Weight: 74