PEMF - PHYSIO-STIM 655315-0001Recalls & reported problems
Orthofix US LLC · 5315, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18257200132010), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 injury.
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
- Insufficient Device Problem Information1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Insufficient Device Problem Information
ACCORDING TO INFORMATION RECEIVED VIA MEDWATCH REPORT: THE PATIENT REPORTED THE DEVICE CAUSED A CYCT ON HER BACK TO RUPTURE RESULTING IN SIGNIFICATN BRUISING AND PAIN. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain
MAUDE report 24715633 ↗
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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