InjuryLOF

CERVICAL STIM

Received Jun 26, 2026 · Event occurred Jun 9, 2026

Report 2183449-2026-00035 · MDR key 25641769

Device

Generic name

Bone Growth Stimulator, Cervical Stim

Manufacturer

Orthofix, Llc

Model number

5505

Catalog number

655505-0021

Product problems

Adverse Event Without Identified Device or Use Problem
Insufficient Device Problem Information

Patient

76 YR · Female

Burn(s)

Narrative

Additional Manufacturer Narrative

THE DEVICE HAS NOT RETURNED FOR INVESTIGATION. IF THE DEVICE RETURNS AN INVESTIGATION WILL BE PERFORMED AT THAT TIME. DHR HAS BEEN REVIEWED AND ALL DEVICES PASSED FINAL INSPECTION.

Description of Event or Problem

PATIENT REPORTED FEELING A BURNING SENSATION ON HER BACK AND IT LOOKED RED. PATEINT STATED THE UNIT FELT HOT AND BURNED THE SKIN ON HER UPPER BACK AND NECK. PATIENT STATED THE NURSE OBSERVED BLISTERS AS WELL.