MAUDE Adverse Event Report: ORTHOFIX, LLC PEMF- CERVICAL-STIM; BONE GROWTH STIMULATOR

Catalog Number	655505-0001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not returned.If the device is returned we will perform an nivestigation.
Event or Problem Description
Patient called and reported that the device got hot and burned her and left cusion marks on the back of her neck.On (b)(6) 2025 a follow up phone call to patient.Patient stated started using the device on monday (b)(6).On wednesday, (b)(6) patient was outside wearing the device on neck and had an uncomfortable feeling but does not remember the device feeling hot or warm.Patient stated after taking off the device, husband noticed bruising and black mark on area where patient was wearing the device.Patient stated the black mark seemed to be in the shape of the device, and where device was sitting on neck.Patient stated did not seek medical care or going to the doctor after this occurred.Patient stated it was awkward in general to turn when wearing the device.Patient stated is next meeting with doctor on (b)(6).Patient stated have not noticed symptoms getting worse or change to area.Patient stated black mark is still currently on neck area.Patient stated stopped using the device last wednesday after event occurred.Patient stated they had reached out to rep who had given the device to simply notify this had happened.
Additional Manufacturer Narrative
The device was returned for investigation.As received, device was able to power on and charge and pass post.Device completed 4hrs treatment of heating test.No damage noted to system.System operates as designed.A review of the dhr was performed for work order (b)(4).All (b)(4) units from the work order passed final inspection.Based on the complaint description death or serious injury did not occur and is not likely to cause a death or serious injury if a similar incident was to reoccur.
Event or Problem Description
Patient called and reported that the device got hot and burned her and left cushion marks on the back of her neck.On (b)(6) 2025 a follow up phone call to patient.Patient stated started using the device on monday (b)(6).On wednesday, (b)(6) patient was outside wearing the device on neck and had an uncomfortable feeling but does not remember the device feeling hot or warm.Patient stated after taking off the device, husband noticed bruising and black mark on area where patient was wearing the device.Patient stated the black mark seemed to be in the shape of the device, and where device was sitting on neck.Patient stated did not seek medical care or going to the doctor after this occurred.Patient stated it was awkward in general to turn when wearing the device.Patient stated is next meeting with doctor on (b)(6).Patient stated have not noticed symptoms getting worse or change to area.Patient stated black mark is still currently on neck area.Patient stated stopped using the device last wednesday after event occurred.Patient stated they had reached out to rep who had given the device to simply notify this had happened.

• Brand Name: PEMF- CERVICAL-STIM
• Common Device Name: BONE GROWTH STIMULATOR
• 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: 22194779
• Report Number: 2183449-2025-00020
• Device Sequence Number: 12296937
• Product Code: LOF
• UDI-Device Identifier: 18257200105632
• UDI-Public: 18257200105632
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P850007
• 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,Followup
• Report Date (Section B): 08/05/2025

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 Catalogue Number: 655505-0001
• Device Lot Number: 0049658044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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: 63 YR
• Patient Sex: Female