MAUDE Adverse Event Report: ORTHOFIX US LLC ACCELSTIM; BONE GROWTH STIMULATOR

Model Number	654300-0001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	High Blood Pressure/ Hypertension (1908)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Several attempts were made to retrieve the device with no good results.A review of the dhr was performed - all 100 units from the work order passed final inspection.Should the device return for investigation, failure analysis will be completed.
Event or Problem Description
The patient claimed the device raised her blood pressure caused her to go to the emergency room.On (b)(6) 2025, a call was made to the patient to gain additional information.Patient declined to provide additional details regarding her experience.

• Brand Name: ACCELSTIM
• Common Device Name: BONE GROWTH STIMULATOR
• Manufacturer (Section D): ORTHOFIX US LLC; 3451 plano pkwy; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX US LLC; 3451 plano pkwy; lewisville TX 75056
• Manufacturer Contact: yobana sanchez ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 22569918
• Report Number: 2183449-2025-00023
• Device Sequence Number: 9247790
• Product Code: LOF
• UDI-Device Identifier: 08050040997213
• UDI-Public: 08050040997213
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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: 654300-0001
• Device Catalogue Number: 4300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female