ENDOBON® ROX05Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03599870091258), received between Jan 9, 2019 and Aug 27, 2021 — classified as 11 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (9 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2021Failure to Osseointegrate; Failure to Osseointegrate

  IT HAS BEEN REPORTED THAT THE PATIENT HAD A LOSS OF INTEGRATION AND INFECTION WITH PAIN AND INFLAMMATION AFTER A ENDOBON XENOGRAFT IMPLANTATION. DOCTOR PERFORMED RECONSTRUCTION.

  Patient problems: Inadequate Osseointegration; Inflammation; Pain; Unspecified Infection

  MAUDE report 12376477 ↗
• InjuryJul 6, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED LOSS OF INTEGRATION FOR ENDOBON GRAFT PLACED AT TOOTH SITE 24, AROUND 5 MONTHS AFTER IMPLANTATION. ENDOBON GRAFT HAS BEEN REMOVED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10232369 ↗
• InjuryDec 16, 2019Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED BY THE DOCTOR NON INTEGRATION OF ENDOBON. CUSTOMER REQUESTS COMPENSATION. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020 EXPLAIN THAT CURETTAGE HAS BEEN PERFORMED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9472149 ↗
• InjurySep 16, 2019Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT T3 IMPLANT WAS PLACED IN 2014 WITH SIMULTANEOUS AUGMENTATION OF BUCCAL BONE LAMELLA WITH ENDOBON XENOGRAFT AND OSSEOGUARD MEMBRANE. THE PATIENT BONE DENSITY IS TYPE III, THE IMPLANT INTEGRATED OPTIMALLY AND SHOWED NO ABNORMALITY AFTER PROSTHETIC RESTORATION. AS PER PATIENT´S LAWYER STATEMENT, ENDOBON PRODUCTS CAUSED PAIN, SWELLING, NUMBNESS, DIZZINESS, PARAESTHESIA, HYPESTHESIA AROUND THE EYE, AND TINNITUS TO THE PATIENT. ALSO, LAWYER CLAIMS THAT ENDOBON IS A NON-RESORBABLE CERAMIC THAT REMAINS IN THE BODY AND CAUSES HARM. FURTHERMORE, THE LAWYER AFFIRMS THAT THE RECONSTRUCTION OF THE VESTIBULAR LAMELLA IS NOT INDICATED ACCORDING TO MANUFACTURER'S INSTRUCTIONS, AND THAT THERE WAS A RECALL FOR ENDOBON WITH EXPIRATION DATE 31 AUGUST16 DUE TO INFLAMMATIONS AND SOFT TISSUE IRRITATIONS. DOCTOR DOES NOT SHARE LAWYER´S OPINION. THE PATIENT FEARS THAT ENDOBON CAUSES NEUROLOGICAL FAILURES.

  Patient problems: Dizziness; Hypoesthesia; Numbness; Pain; Swelling; Tinnitus

  MAUDE report 9069318 ↗
• InjuryFeb 1, 2019Failure to Osseointegrate; Failure to Osseointegrate

  IT HAS BEEN REPORTED THAT THE PRODUCT ENDOBON XENOGRAFT DID NOT INTEGRATE. ENDOBON PLACEMENT PERFORMED THE (B)(6) 2018 AND THE PRODUCT REMOVAL PERFORMED ON (B)(6) 2018.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8297677 ↗
• InjuryJan 29, 2019Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT THE BIOMATERIAL WAS NOT INTEGRATED AND AS A RESULT THE BONE MATERIAL WAS NOT COMPACTED CAUSING THE IMPLANT FAILURE. BIOMATERIAL WAS PLACED ON (B)(6) 2016, THE IMPLANT WAS PLACED ON (B)(6) 2017 AND THE NON INTEGRATION APPEARED ON (B)(6) 2018.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8284873 ↗
• InjuryJan 22, 2019Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT FOLLOWING A NON INTEGRATION OF THE BIOMATERIAL, THE BONE MATERIAL WAS NOT COMPACTED, WHICH RESULTED IN IMPLANT FAILURE. THE BIOMATERIAL WAS PLACED ON (B)(6) 2017, IMPLANT WAS PLACED ON (B)(6) 2018 AND NON INTEGRATION APPEARED ON (B)(6) 2018.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8266273 ↗
• InjuryJan 22, 2019Failure to Osseointegrate; Failure to Osseointegrate

  IT HAS BEEN REPORTED THAT FOLLOWING NON INTEGRATION OF THE BIOMATERIAL, THE BONE MATERIAL WAS NOT COMPACTED CAUSING AN IMPLANT FAILURE. THE BIOMATERIAL WAS PLACED ON (B)(6) 2017, THE IMPLANT WAS PLACED ON (B)(6) 2017 AND NON INTEGRATION APPEARED ON (B)(6) 2018.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8266249 ↗
• InjuryJan 16, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PLEASE REFER TO REPORT 3006946279-2019-00042.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8251940 ↗
• InjuryJan 15, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PLEASE REFER TO REPORT 3006946279-2019-00045.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8247691 ↗
• InjuryJan 9, 2019Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT THE PRODUCT BONE GRAFT (ENDOBON) DID NOT SEEM TO BE INTEGRATED IN SIX MONTHS EVEN WITH THE MEMBRANE USED. THE IMPLANT WAS PLACED ON (B)(6) 2018 AND WAS REMOVED ON (B)(6) 2018.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8231538 ↗