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
This incident is related to a skin irritation problem.Konix gel k101952 is a component of the device.There were no dysfunction, deficiencies/deteriorations found with the device.No device malfunction has occurred.The review has determined that the risk assessment is still adequate.
Event or Problem Description
Information provided states that patient was prescribed accelstim device (b)(6) 2022.Pt said she only used it 3-4 times.After last treatment red burns appeared about the size of the device on her foot, 2-3 burns on the back bottom of her foot where the device was and on the top of the foot.She stopped using the device.Patient said the burns have since healed.Pt stated she tried alternative mineral oil and glycerin with the same results.
Additional Manufacturer Narrative
Analysis of the returned device was completed on 08 may 2023.Five therapy sessions were conducted, with the last session occurring on (b)(6) 2023, lasting 10 minutes.During the treatment, device temperature was continuously monitored and never exceeded 25°c.Following the treatment, a burn-in test was conducted, which revealed no errors.Additionally, a force balance assessment was performed to determine ultrasound intensity value, and no deviations were detected.

• Brand Name: ACCELSTIM
• Common Device Name: BONE GROWTH STIMULATOR
• Manufacturer (Section D): ORTHOFIX; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX; 3451 plano parkway; lewisville TX 75056
• Manufacturer Contact: james stephens ; 3451 plano parkway; lewisville, TX 75056 ; 4698913525
• MDR Report Key: 17059858
• Report Number: 2183449-2023-00001
• Device Sequence Number: 14735020
• Product Code: LOF
• UDI-Device Identifier: 08050040997213
• UDI-Public: 08050040997213
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/28/2024

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: 11/01/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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