EBI OsteoGen Implantable Bone Growth Stimulator 10-1318Recalls & reported problems
Ebi, LLC · OSteoGen 20/F · Class 3
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 00812301020010), received between Jun 24, 2026 and Jun 24, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 other recall cover devices cleared under the same FDA submission (P790005); they may or may not involve this specific model.
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
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2026Insufficient Device Problem Information
THE PATIENT REPORTED THAT THE DEVICE STOPPED FUNCTIONING APPROXIMATELY SIX MONTHS AFTER IMPLANTATION. THE PATIENT STATED THAT THE DEVICE HAD BEEN RECALLED AND EXPRESSED CONCERNS REGARDING THE AVAILABILITY OF RECORDS AND ASSISTANCE RELATED TO THE IMPLANT. THE PATIENT REFERENCED OSTEOGEN, A TIBIAL FRACTURE, HER COCCYX, AND CONCERNS THAT THE IMPLANT HAD MOVED WITHIN HER BODY. THE PATIENT REPORTED BEING UNABLE TO OBTAIN DEVICE REMOVAL AND STATED THAT HEALTHCARE PROVIDERS HAD ONLY OFFERED PAIN MANAGEMENT. THE PATIENT STATED THAT SHE WAS GIVEN PAIN KILLERS. THE PATIENT INDICATED AN INTENT TO PURSUE LEGAL ACTION. THE PATIENT WAS INFORMED THAT, IF THE REFERENCED DEVICE WAS THE PRODUCT IN QUESTION, ITS INTENDED THERAPEUTIC ACTIVITY DURATION IS APPROXIMATELY 24 WEEKS AND THAT REMOVAL MAY BE PERFORMED BY A PHYSICIAN WHEN CLINICALLY INDICATED. THE CALL ENDED BEFORE ADDITIONAL INFORMATION COULD BE OBTAINED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25614372 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P790005. One submission often covers many models, so check the product and lot details in each record.
- Z-0286-2019 · Feb 19, 2018 · TerminatedEBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
Other Stimulator, Invasive Bone Growth devices
- SpF®-PLUS-Mini (60 uA/M) 10-1398MEbi, LLC · Stimulator, Invasive Bone Growth7 reports
- SpF XL IIb Implantable Spinal Fusion Stimulator 10-1335MEbi, LLC · Stimulator, Invasive Bone Growth7 reports
- EBI OsteoGen™ Implantable Bone Growth Stimulator 10-1320MEbi, LLC · Stimulator, Invasive Bone Growth2 reports
- SpF®-XL IIb Implantable Spinal Fusion Stimulator 10-1335WEbi, LLC · Stimulator, Invasive Bone Growth1 report
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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