MAUDE Adverse Event Report: Orthofix, LLC PEMF - PHYSIOSTIM; BONE GROWTH STIMULATOR, PHYSIOSTIM

Model Number	5303
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the device burned the skin, dark spots after each use.
Event or Problem Description
It was reported the device burned the skin, dark spots after each use.
Additional Manufacturer Narrative
Device involved in this event has not been returned for investigation, but it has been requested to return.If the device is returned an investigation will be completed and a follow up report will be submitted.A review of the dhr was performed and all devices passed final inspection.
Additional Manufacturer Narrative
The device returned for investigation.As received, device was able to power on and charging and pass post.Device completed 3hrs treatment of heating test.No damage noted to the system.System operates as designed.A review of the dhr was performed and all devices passed final inspection.

• Brand Name: PEMF - PHYSIOSTIM
• Common Device Name: BONE GROWTH STIMULATOR, PHYSIOSTIM
• 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: 25300887
• Report Number: 2183449-2026-00025
• Device Sequence Number: 18465092
• Product Code: LOF
• UDI-Device Identifier: 18257200131976
• UDI-Public: 18257200131976
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 5303
• Device Catalogue Number: 655303-0001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/09/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2026
• 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: 51 YR
• Patient Sex: Female