Orthofix Osteogenesis Stimulator 2212Recalls & reported problems
Orthofix US LLC · Spinal-Stim Osteogenesis Stimulator · Class 2
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 18257200080793), received between May 18, 2016 and May 18, 2016 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
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.
InjuryMay 18, 2016Adverse Event Without Identified Device or Use Problem
INFORMATION PROVIDED STATES THAT PATIENT BEGAN USING THE SPINAL STIMULATION UNIT IN (B)(6) 2016. PT STATED THAT SHE BEGAN EXPERIENCING PAIN ON (B)(6) 2016 IN THE SAME AREA THAT SHE HAD SHINGLES WHEN IN HER 20'S. PT SAW INFECTIOUS DISEASE DOCTOR AND WAS TOLD THAT SHE HAD 2ND DEGREE BURNS.
Patient problems: Pain
MAUDE report 5664606 ↗
Other Stimulator, bone growth, non-invasive devices
- Biomet SpinalPak Non-invasive Spine Fusion Stimulator System 1067716Ebi, LLC · Stimulator, Bone Growth, Non-Invasive1 recall1 death262 reports
- 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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