InjuryLOF
PEMF - SPINAL STIM
Received Feb 10, 2026 · Event occurred Jan 16, 2026
Report 2183449-2026-00002 · MDR key 24305935
Device
Generic name
Bone Growth Stimulator
Manufacturer
Orthofix, LlcModel number
655212-0021Catalog number
5212
Product problems
- Insufficient Device Problem Information
Patient
75 YR · Female
- Skin Burning Sensation
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS REQUESTED TO RETURN FOR INVESTIGATION, BUT IT WAS NOT RETURNED. NO INVESTIGATION COULD BE PERFORMED. IF THE DEVICE RETURNS AT A LATER DATE THE INVESTIGATION WILL BE PERFORMED AT THAT TIME. A REVIEW OF THE DHR WAS PERFORMED AND ALL UNITS FROM THE WORK ORDER PASSED INSPECTION.
Description of Event or Problem
PATIENT CALLED AND REPORTED A BURNING SENSATION IN THE FRONT LOWER ABDOMEN AND ON THE SIDE. PATIENT STATED THE DEVICE WAS GETTING HOT AND BURNING.