MAUDE Adverse Event Report: ORTHOFIX, LLC BIOSTIM; 5505, SHIP ASSY., OSTEOGENESIS STIMULATOR, CERVICAL-STIM, US

Model Number	655505-0001
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Burn(s) (1757); Nausea (1970); Dizziness (2194)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient called and reported that she was rushed to the emergency room.She was wearing the device and stepped in a puddle and stated the unit electrocuted her body and there were burns.Patient stated that she lost functionality of her upper and lower extremities for a perios of time, became dizzy, disoriented and nauseous.
Additional Manufacturer Narrative
The device was returned for investigation 4/18/2022.It was confirmed device met design specification.A review of the dhr was performed for work order (b)(4).All (b)(4) units from the work order passed final inspection.Orthofix continues to monitor product on the market.

• Brand Name: BIOSTIM
• Common Device Name: 5505, SHIP ASSY., OSTEOGENESIS STIMULATOR, CERVICAL-STIM, 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: 21712159
• Report Number: 2183449-2025-00015
• Device Sequence Number: 4745276
• Product Code: LOF
• UDI-Device Identifier: 18257200105632
• UDI-Public: 18257200105632
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 03/27/2025

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: 10/07/2022
• Device Model Number: 655505-0001
• Device Catalogue Number: 5505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• 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: 61 YR
• Patient Sex: Female