MAUDE Adverse Event Report: ORTHOFIX, LLC ACCELSTIM; 4300, SHIP ASSY, ACCELSTIM, BONE GROWTH STIMULATOR, US

Model Number	4300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
5 therapies carried out, last therapy on (b)(6) 2023 (10 mins), we started a device treatment and during the treatment we measured the device temperature.During treatment, device never had exceeded 25 c.After the treatment, burn-in test was performed resulting in no errors.Force balance performed to get ultrasound intensity value; no deviation found.No device malfunction has occurred.The review has determined that the risk assessment is still adequate.
Event or Problem Description
Patient called and reported that she tried a different type of gel, which she used a mineral oil/baby oil and the unit has burned her for the second time.Patient was unable to provide pictures and stated that the burn has healed.

• Brand Name: ACCELSTIM
• Common Device Name: 4300, SHIP ASSY, ACCELSTIM, BONE GROWTH STIMULATOR, 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: 21678918
• Report Number: 2183449-2025-00012
• Device Sequence Number: 12704854
• Product Code: LOF
• UDI-Device Identifier: 08050040997213
• UDI-Public: 08050040997213
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 06/02/2023
• Device Model Number: 4300
• Device Catalogue Number: 654300-0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• 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: 36 YR
• Patient Sex: Female