MAUDE Adverse Event Report: ORTHOFIX MEDICAL BONE GROWTH STIMULATOR; CERVICALSTIM

Model Number	5505
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/02/2024
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 experienced chest tightness followed by warmness and buring during his 4th treatment.Patient said the unit was hot.Patient said the lcd burned him through his t-shirt.Patient stated he went to the er and the er doctor said he received a bruise or 1st degree burn.

• Brand Name: BONE GROWTH STIMULATOR
• Common Device Name: CERVICALSTIM
• 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: 20041071
• Report Number: 2183449-2024-00010
• Device Sequence Number: 7978071
• 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: P030034
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2024

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 Expiration Date: 06/21/2025
• 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: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2024
• Is the Device Labeled for Single Use? (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: Other
• Patient Age: 66 YR
• Patient Sex: Male