OSSEOTITE® OSS585Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00844868013303), received between Nov 20, 2019 and Feb 17, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION #19 FAILED DUE TO PERI-IMPLANTITIS.

  Patient problems: Abscess; Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16396497 ↗
• InjuryDec 17, 2021Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13024952 ↗
• MalfunctionOct 19, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WHEN TAKING IMPRESSIONS TO PLACE A CROWN ON AN IMPLANT PLACED ON 2019, THE INTERNAL THREAD STRIPPED OUT. DOCTOR WAS NOT ABLE TO PLACE THE COVER SCREW, HE TRIED TO RE-DO THE THREAD WITHOUT SUCCESS BUT FINNALY MANAGED TO PLACE A CROWN ON (B)(6) 2019.

  Patient problems: No Information

  MAUDE report 10696115 ↗
• InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT LACKED PRIMARY STABILITY WHEN PLACING AND WAS REMOVED.

  Patient problems: No Information

  MAUDE report 10435920 ↗
• InjuryFeb 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT COULD NOT BE PLACED DUE TO LACK OF PRIMARY STABILITY. THE IMPLANT WAS REMOVED AND NO OTHER IMPLANT WAS PLACED.

  Patient problems: No Information

  MAUDE report 9716779 ↗
• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR INDICATED THAT THE IMPLANT OSS585 WAS REMOVED DUE TO AN INFECTION. DOCTOR PERFORMED A CURETTAGE. TOOTH SITE #31.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9350346 ↗