PEMF - PHYSIO-STIM 655302-0001Recalls & reported problems
Orthofix US LLC · 5302, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 18257200131969), received between Dec 6, 2020 and Apr 29, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Insufficient Device Problem Information1
Patient problems
- Swelling/ Edema3
- Blister1
- Burn(s)1
- Discomfort1
- Electric Shock1
- Pain1
- Skin Discoloration1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED FEELING SHOCKING DURING THE TREATMENT. AFTER TREATING WITH THE DEVICE THE PATIENT REPORTED PAIN AND SWELLING ACROSS HER FOOT AND UP HER ANKLE.
Patient problems: Electric Shock; Pain; Swelling/ Edema
MAUDE report 25035827 ↗InjuryApr 9, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SWELLING ON THE BACK OF THE FOOT THAT IS CAUSING BLISTERS AND BLEEDING.
Patient problems: Blister; Swelling/ Edema
MAUDE report 24830501 ↗InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED THE DEVICE MADE HIS LEG(S) SWELL WITH PAIN IN THE LOWER LEG BY THE ANKLE. PATIENT REPORTED DISCOLORATION TO THE TOES AND SAID HIS PHYSICIAN ADVISED TO STOP USING THE DEVICE.
Patient problems: Skin Discoloration; Swelling/ Edema
MAUDE report 23855848 ↗InjuryDec 6, 2020Adverse Event Without Identified Device or Use Problem
INFORMATION PROVIDED STATES THAT PATIENT HAD SURGERY ON (B)(6) 2020 TO REPAIR A DISPLACED FRACTURE OF FIFTH METATARSAL IN HER RIGHT FOOT. PATIENT BEGAN TREATING 3 HOURS PER DAY WITH PHYSIOSTIM DEVICE FROM (B)(6) 2020 TO (B)(6) 2020. PATIENT EXPERIENCED DISCOMFORT AND REMOVED BANDAGES. PATIENT BELIEVES THAT THE PHYSIOSTIM UNIT HAD BURNED HER FOOT. PATIENT CONTACTED SURGEON AND WAS ADMITTED TO HOSPITAL FOR IV ANTIBIOTIC TREATMENTS FOR 2 DAYS.
Patient problems: Burn(s); Discomfort
MAUDE report 10955637 ↗
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- Biomet SpinalPak / OrthoPak 106130-22Ebi, LLC · Stimulator, Bone Growth, Non-Invasive101 reports
- Biomet OrthoPak Non-invasive Bone Growth Stimulator System 1067718Ebi, LLC · Stimulator, Bone Growth, Non-Invasive1 recall41 reports
- Biomet EBI Bone Healing System 1068240Ebi, LLC · Stimulator, Bone Growth, Non-Invasive61 reports
- Biomet SpinalPak / OrthoPak 1067724-2Ebi, LLC · Stimulator, Bone Growth, Non-Invasive1 recall4 reports
- Biomet SpinalPak / OrthoPak 1067724-4Ebi, LLC · Stimulator, Bone Growth, Non-Invasive1 recall2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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