OSSEOTITE® OSS313Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00844868013129), received between Feb 7, 2020 and Sep 30, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Fracture” (13 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Fracture; Loss of Osseointegration

  The doctor reports that the dental implants failed because they fractured by the head & body. Loss of integration was also reported. Tooth sites 24 and 25.The doctor reports that the procedure was not concluded by placing another implants.Bone type: III.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946335 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 22191923 ↗
• InjurySep 16, 2024Fracture; Fracture

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #26 FAILED BECAUSE IT FRACTURED AT THE HEAD. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224299 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT REFERS TO THE TREATED INFECTION MENTIONED IN (B)(4). DOCTOR REPORTED THAT AFTER 2 WEEKS OF IMPLANTATION AT TOOTH SITE 24 THERE WAS INFECTION WITH ABSCESS FORMATION. DESPITE OF INCISION, INTENSIVE FLUSHING AND ANTIBIOTICS PUS WAS FORMED AND IN THE END IMPLANT HAD TO BE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 19772762 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT REFERS TO THE TREATMENT FOR INFECTION. DOCTOR REPORTED THAT AFTER 2 WEEKS OF IMPLANTATION AT TOOTH SITE 24 THERE WAS INFECTION WITH ABSCESS FORMATION. DESPITE OF INCISION, INTENSIVE FLUSHING AND ANTIBIOTICS PUS WAS FORMED AND IN THE END, IMPLANT HAD TO BE REMOVED. (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19772733 ↗
• InjuryJun 19, 2024Fracture; Fracture

  FRACTURE AT THE TOP OF THE IMPLANT AT TOOTH SITE #36. THE APEX OF THE IMPLANT WAS NOT REMOVED AND IT WAS BURIED. ANOTHER IMPLANT WILL BE PLACED IN THE ADJACENT POSITION IN A FUTURE APPOINTMENT. NO OTHER IMPACT ON THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567949 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 37 WAS REMOVED DUE TO NERVE DAMAGE. PARESTHESIA WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Paresthesia

  MAUDE report 18571417 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. AS A CONSEQUENCE OF THE EVENT PAIN AND INFLAMMATION. BAD ORAL HYGIENE.TOOTH LOCATION UNK.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18219636 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITION NUMBER #32, #42 AND #43 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. SITES PRESENTED INFLAMMATION AND EDEMA. PATIENT FELT PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17771692 ↗
• InjuryFeb 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN UNKNOWN POSITION FAILED BECAUSE IT WAS FRACTURED IN THE NECK, THE DOCTOR INDICATES IN THE PER THAT THE PROCEDURE WAS NOT YET CONCLUDED WITH THE PLACEMENT OF OTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383650 ↗
• InjuryFeb 10, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16350332 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INTEGRATION THE PALATINE REGENERATION WAS GREATER THAN THE VESTIBULAR ONE, SO THAT IT MODIFIED THE INSERTION AXIS. THE IMPLANT WAS REMOVED AND FLAP AND SUTURING WERE PERFORMED. TOOTH SITE 23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14278157 ↗
• InjuryJan 3, 2022Fracture; Fracture

  DOCTOR REPORTED THE IMPLANT IN TOOTH LOCATION 36 FRACTURED AT THE BODY OF THE IMPLANT AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13141066 ↗
• InjuryJun 4, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11937786 ↗
• InjuryJun 4, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11937680 ↗
• InjuryNov 5, 2020Fracture; Fracture

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

  Patient problems: No Code Available

  MAUDE report 10792669 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10618833 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (OSS313) WAS REMOVED DUE TO INFECTION AT TOOTH LOCATION 21.

  Patient problems: Unspecified Infection

  MAUDE report 10468703 ↗
• InjuryAug 20, 2020Fracture; Fracture

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

  Patient problems: No Information

  MAUDE report 10429885 ↗
• InjuryMay 8, 2020Fracture; Fracture

  IT WAS REPORTED FRACTURE OF THE IMPLANT AT THE NECK LEVEL.

  Patient problems: No Code Available

  MAUDE report 10037810 ↗
• InjuryMar 11, 2020Fracture; Fracture

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

  Patient problems: No Information

  MAUDE report 9816795 ↗
• InjuryFeb 7, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO FRACTURE. TOOTH LOCATION 19.

  Patient problems: No Information

  MAUDE report 9683837 ↗