MAUDE Adverse Event Report: ORTHOFIX PEMF - PHYSIO STIM; BONE GROWTH STIMULATOR

Model Number	655302-0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Discoloration (2074); Swelling/ Edema (4577)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported the device made his leg(s) swell with pain in the lower leg by the ankle.Patient reported discoloration to the toes and said his physician advised to stop using the device.
Additional Manufacturer Narrative
Patient reported he ended up doing surgery on (b)(6) 2023 to fix his leg after discontinuing use of the device.No additional information was provided and the device is not available for further investigation.

• Brand Name: PEMF - PHYSIO STIM
• Common Device Name: BONE GROWTH STIMULATOR
• Manufacturer (Section D): ORTHOFIX; 3451 plano pkwy; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX; 3451 plano pkwy; lewisville TX 75056
• Manufacturer Contact: yobana sanchez ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 23855848
• Report Number: 2183449-2025-00038
• Device Sequence Number: 12009358
• Product Code: LOF
• UDI-Device Identifier: 18257200131969
• UDI-Public: 18257200131969
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 12/19/2025

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: 655302-0001
• Device Catalogue Number: 5302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2022
• 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: 68 YR
• Patient Sex: Male