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

Model Number	655505-0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been requested to return for investigation.No further details have been provided.If the device is returned an investigation will be performed at that time.A review of the dhr was performed for work order: (b)(4).All 60 units from the work order passed final inspection.Based on the complaint description death or serious injury did not occur and is not likely to cause death or serious injury if a similar incident was to reoccur.
Event or Problem Description
Patient reported the device made his head feel like it was on fire.During a follow up call the patient stated that the unit felt hot and it made his head feel hot.The device has been requested for return.
Event or Problem Description
Patient reported the device made his head feel like it was on fire.During a follow up call the patient stated that the unit felt hot and it made his head feel hot.The device has been requestd for return.
Additional Manufacturer Narrative
The device returned investigation.As received, device was able to power on and charging and pass post.Device was fully charged and completed 4hrs treatment of heating test.No damage noted to system.System operates as designed.A review of the dhr was performed for work order (b)(4).All (b)(4) units from the work order passed final inspection.Based on the complaint description death or serious injury did not occur and is not likely to cause death or serious injury if a similar incident was to reoccur.

• Brand Name: PEMF - CERVICAL STIM
• Common Device Name: BONE GROWTH STIMULATOR
• 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: 23769268
• Report Number: 2183449-2025-00037
• Device Sequence Number: 21490546
• Product Code: LOF
• UDI-Device Identifier: 18257200105632
• UDI-Public: 18257200105632
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 01/09/2026

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
• Device Model Number: 655505-0001
• Device Catalogue Number: 5505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2025
• 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: 76 YR
• Patient Sex: Male