MAUDE Adverse Event Report: BIOVENTUS EXOGEN

Lot Number 15BM03511

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Event Description

Used my bioventus exogen bone healing system on my right ankle for 28 days beginning on or about (b)(6).Beginning at the 8th day, shortly after turning the unit on, mild discomfort was experienced.As the days went by, the discomfort became greater each day until approx the 18th day, at which time the discomfort became pain.The discomfort/pain would last up to several hours after each treatment.By the 21st day the pain experienced became a 4 (on the standard zero to ten pain scale).At this point, the pain locus was not specific to the broken bone area being healed, but would spread throughout the entire ankle area, and would last several hours after treatment.After day 28 i discontinued use of this device.Prior to day 28 i had contacted the bioventus rep and my doctor to inform them of the situation.It took them several days to respond.They conferred with each other and the suggestion was to discontinue use for a week, then resume using the device for only 5 minutes a day for each treatment as opposed to the 20 minutes called for.I did not follow this advice, and continued to not use the device any longer.Contacted the company directly and it took them several days to respond via email.It was a request for information, which was supplied.Several days later i was contacted by a doctor from the company.At the end of this conversation he told me that, while this condition was new to him, it was probably just part of the healing process.I responded by saying that his assessment was unlikely.Yesterday, the company contacted me again via phone.I furnished the same information as i had in the email previously.During that conversation, i came to realize that while we were both talking about the same exogen unit, the appearance of the one i had did not match what the person on the phone was describing.Not much of a discrepancy, but enough to cause me concern.I will state that the unit was used in accordance with the instructions.Ball is now in your court.

• Brand Name: EXOGEN
• Type of Device: EXOGEN
• Manufacturer (Section D): BIOVENTUS
• MDR Report Key: 4847497
• MDR Text Key: 5875496
• Report Number: MW5043077
• Device Sequence Number: 1
• Product Code: LOF
• 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: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 15BM03511
• Patient Sequence Number: 1
• Treatment: METFORMIN; ONGLYZA; VITAMIN D; FISH OIL
• Patient Age: 68 YR
• Patient Weight: 127