MAUDE Adverse Event Report: ORTHOFIX, LLC BONE GROWTH STIMULATOR; SPINAL STIM

Model Number	5212
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient sent an email reporting she believes the device caused burns on her back.No further information was provided.
Additional Manufacturer Narrative
Attempts to reach the patient have been mad to gather additional details with no good results.The device has been returned for evaluation but the investigation is not complete at this time.A review of the device history records was performed - all 56 units from this work order passed final inspection.
Additional Manufacturer Narrative
Attempts to reach the patient have been made to gather additional details with no good results.The device was returned and investigated.As received, device was able to power on and charging and pass post.Device completed two hours treatment of heating test.No damage noted to the system.System operates as designed.A review of the device history records was performed - all (b)(4) units from this work order passed final inspection.
Event or Problem Description
Patient sent an email reporting she believes the device caused burns on her back.No further information was provided.

• Brand Name: BONE GROWTH STIMULATOR
• Common Device Name: SPINAL STIM
• 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: 23350620
• Report Number: 2183449-2025-00029
• Device Sequence Number: 7807114
• Product Code: LOF
• UDI-Device Identifier: 18257200105670
• UDI-Public: 18257200105670
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/18/2025

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: 5212
• Device Catalogue Number: 655212-0001
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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: 51 YR
• Patient Sex: Female