EBI OsteoGen™ Implantable Bone Growth Stimulator 10-1320MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812301020034), received between Mar 26, 2019 and Jan 24, 2025 — classified as 2 injuries.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PLATE AND THE OSTEOGEN IMPLANTED IN (B)(6) 2024. SINCE THEN, THE PATIENT HAS BEEN IN PAIN AND HAS A BURNING SENSATION THAT AT TIMES IS A 10 OUT OF 10. IT WAS NOTED THAT THE PATIENT HAD A KNEE REPLACEMENT 10 YEARS AGO, AND THE PATIENT¿S HUSBAND STATED THAT THE INTERNAL ADHESIVE DID NOT ADHERE. THE ROD WAS MOVING AROUND AND RUBBING THE PATIENT¿S BONE, THUS RUINING THE BONE. IN (B)(6) 2024, THE PATIENT HAD SURGERY WHERE THE ROD WAS REMOVED AND THE KNEE WAS REPLACED AGAIN. 6 MONTHS LATER, THERE WAS NO IMPROVEMENT OR BONE GROWTH, SO THE OSTEOGEN WAS IMPLANTED. THE DISCOMFORT WAS REPORTED TO THE PATIENT¿S DOCTOR AND THE DOCTOR SAID SHE IS STILL HEALING AND WAS UNABLE TO DIAGNOSE WHERE THE PATIENT¿S PAIN WAS COMING FROM. THE DOCTOR RECENTLY DID A 3-PHASE BONE SCAN TO DIAGNOSE THE PATIENT¿S ISSUES, BUT THE RESULTS HAD NOT COME BACK YET. THE PATIENT¿S HUSBAND STATED THAT HE IS NOT ACCUSING THE DEVICE OF CAUSING DISCOMFORT BUT RATHER TRYING TO FIND ANSWERS AND EDUCATE HIMSELF ON HIS WIFE¿S ISSUES. IT WAS LATER REPORTED THAT THE PATIENT¿S LEG IS ALSO RED AND HOT A LOT OF THE TIME. THE PATIENT¿S HUSBAND ONLY CONTACTED CUSTOMER SERVICE REGARDING POSSIBLE S

  Patient problems: Erythema; Pain

  MAUDE report 21232708 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TWO STAGE REVISION DUE TO INFECTION. THE FIRST REVISION SURGERY WAS FOR PLACEMENT OF THE BONE STIMULATOR DUE TO ATROPHIC NON-UNION. DURING A DOCTOR'S OFFICE VISIT, A FEW MONTHS FOLLOWING IMPLANTATION OF THE BONE STIMULATOR, IT WAS NOTICED THAT THE PATIENT HAD A DRAINING WOUND DOWN THE LATERAL ASPECT OF THE HIP. SHE HAD PAIN IN THE RIGHT HIP REGION. X- RAY IMAGES SHOWED A NAIL STABILIZING A SUBTROCHANTERIC FRACTURE WITH THE TIP OF THE BONE STIMULATOR ELECTRODE BELOW THE FRACTURE SITE. THERE WAS A SMALL AMOUNT OF HO FORMATION AROUND THE ELECTRODE. THERE WAS PRESENCE OF AN INFECTED NONUNION OF A RIGHT SUBTROCHANTERIC FRACTURE. THE PATIENT WAS REFERRED TO A HOSPITAL FOR EXPLANT OF THE STIMULATORY, DEBRIDEMENT, POSSIBLE HARDWARE EXCHANGE, AND LONG TERM ANTIBIOTICS.THE SUBSEQUENT REVISION SURGERY OCCURRED 6 MONTHS AFTER THE INITIAL SURGERY, FOR THE REMOVAL OF THE BONE STIMULATOR, AND PLACEMENT OF ANTIBIOTIC IMPREGNATED STEM AND BEAD DUE TO INFECTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 8453439 ↗

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 · Terminated
  EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.