MAUDE Adverse Event Report: ORTHOFIX, INC. ORTHOFIX CERVICALSTIM BONE GROWTH STIMULATOR MODEL 5505; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number 5505

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Burn(s) (1757); Erythema (1840); Irritation (1941); Skin Irritation (2076)

Event Date 08/25/2018

Event Type  Injury  

Event Description

The skin on my chest, and face appears burned from an orthofix cervicalstim bone growth stimulator medical device, and my eyes are irritated from the device.I used the device from (b)(6) through (b)(6) 2018 usually for four hours per day.For the first several weeks i wore the stimulator over an aspen vista cervical collar.The area under the vista collar started to become red and irritated.I though the skin irritation was from the vista collar and in continued using the orthofix device.I answered two phone calls while wearing the medical device.One call from my cell phone and the other from a portable cordless land line phone.Each time i held the phone, the medical device starting making repeated clicking noises.During the time i used the orthofix device, i played games on my cell phone and held the cell phone closer than 7" to the orthofix device.On (b)(6) 2018, i sought medical advice as my skin on my chest and neck was very red, and my face had slight redness by my lips and on my cheeks.I had a sore in the red area on my chest.It was determined that the irritation was probably from the vista cervical collar.From (b)(6) through (b)(6) i used the orthofix device less frequently, and i bolstered the vista collar up from my skin using small pieces of padding.The skin seemed to slightly improve.On (b)(6) 2018, i used the orthofix device for one hour without the vista collar, and the orthofix device was over a tee shirt.After this hour my skin on my chest, neck and face became severely reddened.The red areas again looked and felt like a sunburn and my eyes were sore.I discontinued using the orthofix device.The orthofix device was presented to me out of its box by a nurse.This nurse explained how to use the device.There were no warnings given to me about the device.On (b)(6) 2018, i looked for instructions in the box and found a booklet.On page 15 of the booklet under the heading of "information regarding electromagnetic compatibility and immunity," it states the following: wireless communications equipment such as home network devices, mobile phones, cordless telephones, and their base systems should be kept at least 0.198 m (7.8 in) away from cervicalstim.On (b)(6) 2018, i spoke with (b)(4) from orthofix ((b)(4)).She stated she never heard about the phone issues and asked me what page i found this info on.She expressed her regrets over the situation of my skin and said, she would contact another person to contact me.(b)(4) also stated she would file a report with the fda as all incidents are taken seriously.I have not received any calls at this time from anyone from orthofix.I have taken several pictures of these areas that still are affected, and i do have the device.

• Brand Name: ORTHOFIX CERVICALSTIM BONE GROWTH STIMULATOR MODEL 5505
• Type of Device: STIMULATOR, BONE GROWTH, NON-INVASIVE
• Manufacturer (Section D): ORTHOFIX, INC.
• MDR Report Key: 7846627
• MDR Text Key: 119510335
• Report Number: MW5079577
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5505
• Device Catalogue Number: MODEL 5505 INSTRUCTION MANUAL
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 56