MAUDE Adverse Event Report: ORTHOFIX ACCELSTIM; BONE GROWTH STIMULATOR

Model Number	4300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received and is pending evaluation.
Event or Problem Description
Information provided states that patient was prescribed accelstim device (b)(6) 2022.Pt said she used device for 5 months with no issues.She stated that she has gotten burned twice, once 5 weeks prior to calling customer service and again 3 weeks later.Pt discontinued use of the device.The device was replaced with a new unit.
Additional Manufacturer Narrative
Analysis of the returned device was completed on 09 jun 2023.159 therapies were conducted.The most recent therapy was on march 21, 2023.During two of these treatments, we monitored the temperature on the transducer surface, with the maximum temperature recorded reaching 25.3°c.Additionally, we measured acoustic power values both with and without the power supply connected, resulting in readings of 120 mw and 118 mw, respectively.No temperature-related issues were detected, and there was no confirmation of any malfunction with the device.

• Brand Name: ACCELSTIM
• Common Device Name: BONE GROWTH STIMULATOR
• Manufacturer (Section D): ORTHOFIX; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX SERVICES LLC; 3451 plano parkway; lewisville TX 75056
• Manufacturer Contact: james stephens ; 3451 plano parkway; lewisville, TX 75056 ; 4698913525
• MDR Report Key: 17066044
• Report Number: 2183449-2023-00002
• Device Sequence Number: 6673478
• Product Code: LOF
• UDI-Device Identifier: 08050040997213
• UDI-Public: 08050040997213
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P210035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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: 4300
• Device Catalogue Number: 654300-0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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: 75 YR
• Patient Sex: Female