MAUDE Adverse Event Report: ORTHOFIX US LLC CERVICAL STIM SPINAL FUSION THERAPY; STIMULATOR, BONE GROWTH, NON-INVASIVE

Patient Problem Discomfort (2330)

Event Date 02/17/2024

Event Type  Injury  

Event Description

While wearing the orthofix cervicalstim spinal fusion therapy¿©®? device, i noticed that the outer edges of my ears were uncomfortable while in close proximity (1-2 cm) or while in contact with the device.

• Brand Name: CERVICAL STIM SPINAL FUSION THERAPY
• Type of Device: STIMULATOR, BONE GROWTH, NON-INVASIVE
• Manufacturer (Section D): ORTHOFIX US LLC
• MDR Report Key: 18759193
• MDR Text Key: 336121174
• Report Number: MW5151822
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native