MAUDE Adverse Event Report: ORTHOFIX, LLC CERVICAL STIM; OSTEOGENESIS STIMULATOR, CERVICAL-STIM

Model Number	5505
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hearing Impairment (1881)
Date of Event	03/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for investigation.Confirmed device met design specification and worked as intended.Dhr has been reviewed during investigation and all units from the work order passed final inspection.
Event or Problem Description
Patient reported falling asleep with the device on and the collar slipped up around the jaw area for about one hour.Upon waking the patient reported hearing going out and water/fluid came out of the ear.The patient was seen by the prescribing doctor and was prescribed medication.Patient discontinued use of the device.

• Brand Name: CERVICAL STIM
• Common Device Name: OSTEOGENESIS STIMULATOR, CERVICAL-STIM
• 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: 24792889
• Report Number: 2183449-2026-00010
• Device Sequence Number: 9900507
• Product Code: LOF
• UDI-Device Identifier: 18257200105632
• UDI-Public: 18257200105632
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/06/2026

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 Model Number: 5505
• Device Catalogue Number: 655505-0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2025
• 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 Sex: Male