MAUDE Adverse Event Report: ORTHOFIX OSTEOGENESIS STIMULATOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2017

Event Type  Injury  

Event Description

I used a bone growth stimulator by orthofix prescribed by my orthopedic surgeon.My toe fusion surgery did not fuse and the surgeon prescribed the device to promote bone regrowth.My insurance approved this device based on my doctor's order and the representative told me that if i used it as prescribed and the bone did not fuse, they would refund my out of pocket expense of (b)(6) dollars and repay the insurance (b)(6) as well as (b)(6) dollars.This warranty was confirmed in writing when i got the device.X-rays confirmed that bone regrowth did not occur despite using it as prescribed.I returned the device with doctor's documentation and company said it was prescribed for an 'unapproved' indication and denied my claim.I am a healthcare provider and i used this device in part because of their warranty.

• Brand Name: OSTEOGENESIS STIMULATOR
• Type of Device: OSTEOGENESIS STIMULATOR
• Manufacturer (Section D): ORTHOFIX; 3451 lano parkways; lewisville TX 75056
• MDR Report Key: 7037449
• MDR Text Key: 92456433
• Report Number: MW5073352
• Device Sequence Number: 1
• Product Code: LOF
• 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: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 64