PEMF - PHYSIO-STIM 655303-0001Recalls & reported problems
Orthofix US LLC · 5303, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18257200131976), received between Mar 24, 2025 and May 27, 2026 — classified as 3 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 Problem2
- Insufficient Device Problem Information1
Patient problems
- Burn(s)2
- Blister1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE DEVICE BURNED THE SKIN, DARK SPOTS AFTER EACH USE.
Patient problems: Burn(s)
MAUDE report 25300887 ↗InjuryAug 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED AFTER SIX DAYS OF RECEIVING THE UNIT THE PATIENT FELT A BURNING SENSATION. THE PATIENT WENT TO SEE THE DOCTOR AND THE CAST WAS REMOVED. IT WAS REPORTED THERE WERE BLISTERS ALL OVER THE AREA. PATIENT DISCONTINUED USE OF THE DEVICE. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: Blister
MAUDE report 22914059 ↗InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED THE UNIT HAS STARTED TO SHOCK AND BURN HIM. TREATMENT STARTED ON (B)(6) 2022 AND HE WORE THE UNIT FOR THREE DAYS. PATIENT STATED THAT THE UNIT BUNED AND SHOCKED HIM THOSE THREE DAYS PAND IT LEFT BURN MARKS BUT THE MARKS HAVE SINCE GONE AWAY.
Patient problems: Burn(s)
MAUDE report 21679344 ↗
Other Stimulator, bone growth, non-invasive devices
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- Biomet SpinalPak / OrthoPak 106130-20Ebi, LLC · Stimulator, Bone Growth, Non-Invasive1 death188 reports
- Biomet EBI Bone Healing System 1068234Ebi, LLC · Stimulator, Bone Growth, Non-Invasive171 reports
- 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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