MAUDE Adverse Event Report: ORTHOFIX ACCELSTIM; BONE GROWTH STIMULATOR

Model Number 4300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

The device has been received and is pending evaluation.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 316568477
• Report Number: 2183449-2023-00002
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 08050040997213
• UDI-Public: 08050040997213
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P210035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Female