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

Model Number	655505-0001
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to manufacturer for analysis 4/22/2022.As received, device was able to power on and charging and pass post.After fully charged, device completed 4 hrs treatment and another 4 hrs heating test.No damage noted to system.System operates as designed.A review of the dhr was performed for work order (b)(4).All (b)(4) units from the work order passed final inspection.Orthofix coninues monitoring the devices on the market.
Event or Problem Description
Patient called and reported the device was burning her skin.Patient stated she tried using a towel for extra layers and the unit burned her hand touching it.She is on her neck and chest during and after treatment and unable to wear her brace and had anaphylaxix shock.

• 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: 21677879
• Report Number: 2183449-2025-00011
• Device Sequence Number: 12814563
• Product Code: LOF
• UDI-Device Identifier: 18257200105632
• UDI-Public: 18257200105632
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/24/2025

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: 03/24/2023
• Device Model Number: 655505-0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• 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: 44 YR
• Patient Sex: Female