PHYSIOSTIM
Received Feb 2, 2026 · Event occurred Oct 17, 2025
Report MW5183088 · MDR key 24229066
Device
Generic name
Stimulator, Bone Growth, Non-invasive
Manufacturer
Orthofix Us Llc.Model number
655315-0001Patient
86 YR · Female
- Cyst(s)
- Pain
- Impaired Healing
- Ambulation or Postural Difficulties
- Easy Bruising
Narrative
Description of Event or Problem
REPORTER'S SURGEON RECOMMENDED THIS STIMULATOR DEVICE DUE TO HER HIP BONE NOT HEALING AS QUICKLY AS WANTED. SHE USED THIS DEVICE FOR 3 DAYS, 3 HOURS PER DAY. REPORTER STATES BEING IN A WORSE CONDITION THAN WHEN SHE STARTED USING THE DEVICE. SHE HAD MORE PAIN, HAD TO START GOING TO PHYSICAL THERAPY, AND STARTED USING A CANE. REPORTER STATES HER PAIN BEING UNBEARABLE AND THE SURGEON TELLING HER TO DISCONTINUE USING THE DEVICE. SHE ALSO STATES THAT THE DEVICE BURST A CYST ON HER BACK AND LEFT HER HEAVILY BRUISED. REPORTER STATES FINDING ONLINE THAT THE MANUFACTURER HAS SEVERAL CLASS ACTION LAWSUITS AGAINST THEM.