OSSEOTITE® 2 XFOS411Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844868023852), received between Jan 9, 2020 and Jun 9, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (2 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITE 15 OBSERVED DURING THE CLINICAL PROCEDURE. PLACEMENT OF RIGHT UPPER MAX IMPLANT AT TOOTH SITE 15 WITH USUAL FLAP AND SUTURING. WITHDRAWAL OF STITCHES 11 DAYS LATER. ON (B)(6), PATIENT WENT TO CLINIC DUE TO INFLAMMATION AND ABSCESS; PERI-IMPLANTITIS AND IMPLANT MOBILITY WAS DETECTED AND IMPLANT WAS REMOVED. THE PROCESS WAS COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22165466 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A BONE LOSS AT TOOTH SITE #44. IMPLANT WAS REMOVED. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 21631522 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #25. IMPLANT WAS COMPLETELY REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20308524 ↗
• InjuryDec 15, 2023Mechanical Problem; Mechanical Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336986 ↗
• InjuryDec 15, 2023Mechanical Problem; Mechanical Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336937 ↗
• MalfunctionNov 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 19 FRACTURED AT THE NECK PORTION. ADDITIONAL APPOINTMENT REQUIRED: YES, TO REMOVE AND PLACE A NEW IMPLANT. BOTTOM PART REMAINS IMPLANTED.

  Patient problems: No Information

  MAUDE report 10883683 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT DID NOT ACHIEVE PRIMARY STABILITY AND WAS REMOVED. MEMBRANE AND BONE WERE PLACED FOR REGENERATION. PATIENT PRESENTED EDEMA, DEHISCENCE AND INFLAMMATION.

  Patient problems: Edema; Inflammation; Wound Dehiscence

  MAUDE report 9568183 ↗