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	04/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has not returned for investigation.If the device is returned, we will conduct an investigation.
Event or Problem Description
It was reported that the patient stated the patient was shocked during treatment by the device.It was reported there was a red burn mark where the device sits.
Event or Problem Description
Patient reported they were shocked during tratment by the device.It was reported there was a red burn mark where the device sits.
Additional Manufacturer Narrative
The device returned for investigation.There is no noted sign of damage to power supply, device controller or foam coil.Wrapped the device controller enclosure, and device foam coil, and passed all leakage current testing using gw instek (b)(4).Design/manufacture meets spec.A review of the device history records indicates that all 56 units in this lot passed inspection and were functioning as intended.No anomalies found.

• 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: 21987456
• Report Number: 2183449-2025-00017
• Device Sequence Number: 8302543
• Product Code: LOF
• UDI-Device Identifier: 18257200105670
• UDI-Public: 18257200105670
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/16/2025

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: 04/22/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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: 76 YR
• Patient Sex: Male