MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. EBI SPF-XL IIB BONE GROWTH STIMULATOR; STIMULATOR, INVASIVE BONE GROWTH

Model Number 10-1335M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 11/14/2006

Event Type  Injury  

Event Description

I had an ebi spf-xl iib bone growth stimulator, the model is unk, sn is (b)(4).I have suffered swelling, infection, nerve pain, chronic pain and the inability to live a normal life since.No physician would take it out.In january of this year a pain mgmt dr finally took it out and the infections and horrible pain cleared, and the ability to live is now coming back.A medical device should not cause people harm the way that stimulator did to me.I lost 12 years of my life for something implanted that died 6 months after it was installed.Fda safety report id# (b)(4).

• Brand Name: EBI SPF-XL IIB BONE GROWTH STIMULATOR
• Type of Device: STIMULATOR, INVASIVE BONE GROWTH
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.
• MDR Report Key: 8582592
• MDR Text Key: 144415110
• Report Number: MW5086389
• Device Sequence Number: 1
• Product Code: LOE
• Combination Product (y/n): N
• 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: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10-1335M
• Device Catalogue Number: 10-1335M
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 56 YR
• Patient Weight: 55