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

Model Number	655315-0001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not returned for investigation.If the device returns an investigation will be performed at that time.A review of the dhr was performed.All units from the work order passed final inspection.
Event or Problem Description
According to information received via medwatch report: the patient reported the device caused a cyct on her back to rupture resulting in significatn bruising and pain.No additional information has been provided.

• Brand Name: PHYSIOSTIM BONE GROWTH STIMULATOR
• Common Device Name: PHYSIOSTIM 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: 24715633
• Report Number: 2183449-2026-00007
• Device Sequence Number: 14888049
• Product Code: LOF
• UDI-Device Identifier: 18257200132010
• UDI-Public: 18257200132010
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 03/27/2026

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: 655315-0001
• Device Catalogue Number: 5315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR
• Patient Sex: Female