ENDOBON® ROX20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03599870091272), received between Nov 8, 2019 and Nov 8, 2019 — 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BONE GRAFT SURGERY ON (B)(6), 2017. ON (B)(6), 2017 BONE EXPOSURE AND HEALING DELAY WAS REPORTED. ON (B)(6) 2018 IMPLANT (COMPETITOR IMPLANT) HAD CUTANEOUS ABCESS THAT IS LOCALIZED COLLECTION OF PUS IN THE SKIN. IMPLANT REMAINS IMPLANTED. AS A RESULT OF THE EVENT PATIENT HAD BONE LOSS, HEALING DELAY, EDEMA, HYPERESTHESIA, INFECTION, INFLAMMATION , PAIN AND BONE EXPOSURE. PATIENT WOULD NEED TO COME BACK TO MEDICAL OFFICE TO OPEN A FLAP FOR EXPLORATION AND TO PERFORM A NEW BONE GRAFT WITH MEMBRANE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Debris, Bone Shedding; Edema; Inflammation; Pain; Unspecified Infection

  MAUDE report 9294994 ↗