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

Model Number	655303-0001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Blister (4537)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported after six days of receiving the unit the patient felt a burning sensation.The patient went to see the doctor and the cast was removed.It was reported there were blisters all over the area.Patient discontinued use of the device.No further details were provided.
Additional Manufacturer Narrative
The device has not returned for investigation but has been requested to be returned.A review of the the dhr was performed - all 60 units from the work order passed final inspection.Should the device return for investigation, failure analysis will be performed at that time.
Additional Manufacturer Narrative
The device returned for investigation.As received, device was able to power on and charge and pass post.Device completed 3 hours of treatment heating test.No damage noted to the system.System operated as designed.A review of the the dhr was performed - all 60 units from the work order passed final inspection.Orthofix continues to monitor reported incident under trend analysis.
Event or Problem Description
It was reported after six days of receiving the unit the patient felt a burning sensation.The patient went to see the doctor and the cast was removed.It was reported there were blisters all over the area.Patient discontinued use of the device.No further details were provided.

• Brand Name: BIOSTIM
• 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: 22914059
• Report Number: 2183449-2025-00025
• Device Sequence Number: 21096132
• Product Code: LOF
• UDI-Device Identifier: 18257200131976
• UDI-Public: 18257200131976
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/11/2025

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: 655303-0001
• Device Catalogue Number: 5303
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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: Female