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

Model Number	655212-0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Burning Sensation (4540)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported feeling the device and body was getting warm after an hour of treatment.Patient reported noticing it two weeks after initial treatments started.The sensation went away after stopping treatment and also mentioned reflux with similar onset of treating with the device.
Additional Manufacturer Narrative
As received, device was able to power on and charging and pass post.Device completed 2hrs 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 a death or serious injury if a similar incident was to reoccur.

• Brand Name: PEMF-SPINAL 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: 23743339
• Report Number: 2183492-0250-00033
• Device Sequence Number: 8460153
• Product Code: LOF
• UDI-Device Identifier: 18257200105670
• UDI-Public: 18257200105670
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/08/2025

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
• Device Model Number: 655212-0001
• Device Catalogue Number: 5212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2025
• 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: 70 YR
• Patient Sex: Male