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

Model Number	5302
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Blister (4537); Swelling/ Edema (4577)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing swelling on the back of the foot that is causing blisters and bleeding.
Additional Manufacturer Narrative
The device was 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 system.System operates as designed.Dhr was reviewed during the investigation and all units from the work order passed 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: 24830501
• Report Number: 2183449-2026-00008
• Device Sequence Number: 10430386
• Product Code: LOF
• UDI-Device Identifier: 18257200131969
• UDI-Public: 18257200131969
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 04/09/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 5302
• Device Catalogue Number: 655302-0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2025
• 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: 50 YR
• Patient Sex: Male