MAUDE Adverse Event Report: ORTHOFIX, LLC BONE GROWTH STIMULATOR; CERVICAL STIM

Model Number	5505
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has not returned for investigation.If the device is returned, we will conduct an investigation.
Event or Problem Description
Patient called and reported she treats for 4-hours per day and 10 minutes into treating she feels a burning sensation on the back of her neck.Patient also reported red marks on the back of her neck starting (b)(6) 2025.Patient's surgeon requested that she stop use of the device for two weeks.When patient tried to continue use after two weeks, she stated she still feels a burning sensation.Surgeon requested the patient discontinue use of the device.

• Brand Name: BONE GROWTH STIMULATOR
• Common Device Name: CERVICAL STIM
• Manufacturer (Section D): ORTHOFIX, LLC; 3451 plano pkwy; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX, LLC; 3451 plano pkwy; lewisville TX 75056
• Manufacturer Contact: yobana sanchez ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 21980234
• Report Number: 2183449-2025-00016
• Device Sequence Number: 9021120
• Product Code: LOF
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P850007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 5505
• Device Catalogue Number: 655505-0011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Female