InjuryLOF
SPINAL STIM
Received Jun 26, 2026 · Event occurred Jun 16, 2026
Report 2183449-2026-00034 · MDR key 25642007
Device
Generic name
Osteogenesis Stimulator, Spininal Stim
Manufacturer
Orthofix, LlcModel number
5212Catalog number
655212-0001
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
72 YR · Male
- Burn(s)
Narrative
Additional Manufacturer Narrative
THE DEVCIE 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 THE DEVICE LEFT VERTICAL AND HORIZONTAL RED MARKS AFTER USING THE DEVICE. PATIENT STATED THE DEVICE GOT VERY HOT TO THE TOUCH.