MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK INFUSE BONE GRAFT RHBMP-2/ACS; BONE GRAFT 1.4ML

Lot Number M111058AAJ

Device Problems Device Slipped (1584); Structural Problem (2506); Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Muscle Spasm(s) (1966); Pain (1994); Tissue Damage (2104); Reaction (2414)

Event Date 09/19/2011

Event Type  Injury  

Event Description

Surgery: (b)(6) 2011, medtronic infuse, bmp, l5 si fusion, immediate severe muscle spasm with excruciating pain which continues today despite revision surgery (b)(6) 2014.Side effects experienced/documented include: edema, bony outgrowth, lowe l5, increased pain, "enhancement of posterior paraspinous soft tissues", "mild reactive endplate enhancement", arachnoiditis,.[and so on].It is my experience that the fusion occurred approximately 6 months postoperative (original surgery) then began to erode causing loosening of the hardware and screws and eventually failure of all screws and associated unbearable pain.Original surgeon used bmp on the hardware itself adding additional complication to symptoms.All of this made diagnosis extremely difficult for doctors after surgery.Bone that grew [from bmp] was reported to be brittle and not strong.The reabsorption of the bone that grew is known, but not documented anywhere that i could find.I have experienced nearly all the "now reported" side effects of bmp.Please remove this from the market so that others do not have to experience a lifetime of unbearable pain.This has ruined my life and that's putting it mildly.The cost to me in terms of professional and personal life is un-measurable.

• Brand Name: INFUSE BONE GRAFT RHBMP-2/ACS
• Type of Device: BONE GRAFT 1.4ML
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK
• MDR Report Key: 4368518
• MDR Text Key: 5259312
• Report Number: MW5039819
• 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: 12/22/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/01/2012
• Device Lot Number: M111058AAJ
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 100