MAUDE Adverse Event Report: ORTHOFIX MEDICAL; Stimulator, bone growth, non-invasive

Model Number	5505
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has not been returned for investigation.If device is returned we will conduct an investigation.
Event or Problem Description
It was reported that the patient noticed burning/redness after removing the device on (b)(6) 2024.Phone call was made to patient on (b)(6) 2024.Patient stated that for about 4 days she would notice it would get warm on her neck and she would push unit back.Patient stated she then noticed neck feeling itchy and tight.Patient stated at that time her husband looked at it and told her there was a burn on her neck.Patient reported peeling in 1" x 2" strips for two weeks.Patient stated she called the prescribing physician and was told to discontinue use.Patient expressed concern over possible long-term effects.Patient has not returned device at this time.

• Common Device Name: Stimulator, bone growth, non-invasive
• Manufacturer (Section D): ORTHOFIX MEDICAL; 3451 plano pkwy; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX; 3451 plano pkwy; lewisville TX 75056
• Manufacturer Contact: james stephens ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 20634238
• Report Number: 2183449-2024-00022
• Device Sequence Number: 20674439
• Product Code: LOF
• UDI-Device Identifier: 18257200105632
• UDI-Public: 18257200105632
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P03004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

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
• Device Expiration Date: 04/25/2025
• Device Model Number: 5505
• Device Catalogue Number: 655505-0001
• 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: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Female