MAUDE Adverse Event Report: ORTHOFIX, LLC BIOSTIM; 5303, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US

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	10/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device returned for analysis.Device was able to be fully charged and completed 9 hrs treatment.No heating test was processed due to prescription expired and no more treatment allowed.Cui dc ps was returned with the system.Dc power supply, battery pack, and system stimulation output parameters were tested, and are all within device specification, no anomalies noted.Prior current leak testing, visual inspection shows no noted sign of damage to power supply, device controller or foam coil.Wrap the external power supply, the device controller enclosure, and device foamed coil in foil, and passed all leakage current testing using gw instek glc-9000.A review of the dhr was performed for work order (b)(4) and all (b)(4) units from the work order passed final inspection.The review has determined that the risk assesment is still adequate.
Event or Problem Description
Patient reported the unit has started to shock and burn him.Treatment started on (b)(6) 2022 and he wore the unit for three days.Patient stated that the unit buned and shocked him those three days pand it left burn marks but the marks have since gone away.

• Brand Name: BIOSTIM
• Common Device Name: 5303, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
• 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: 21679344
• Report Number: 2183449-2025-00013
• Device Sequence Number: 7693299
• Product Code: LOF
• UDI-Device Identifier: 18257200131976
• UDI-Public: 18257200131976
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/24/2025

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 Expiration Date: 01/20/2023
• Device Model Number: 5303
• Device Catalogue Number: 655303-0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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: 73 YR
• Patient Sex: Male