TRICAM Dental Implant System 305011Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00614950005284), received between Feb 10, 2016 and May 18, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (19 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Failure to Osseointegrate

  IMPLANT FAILED TO OSSEOINTEGRATE.

  Patient problems: Insufficient Information

  MAUDE report 25209286 ↗
• InjuryFeb 7, 2024Failure to Osseointegrate; Failure to Osseointegrate

  DID NOT OSSEOINTEGRATE AFTER 8 WEEK HEALING PERIOD.

  Patient problems: Failure of Implant

  MAUDE report 18659547 ↗
• InjuryAug 17, 2023Failure to Osseointegrate; Failure to Osseointegrate

  NO PRIMARY STABILITY.

  Patient problems: Failure of Implant

  MAUDE report 17568630 ↗
• InjuryAug 16, 2023Loss of Osseointegration; Loss of Osseointegration

  NO PRIMARY STABILITY.

  Patient problems: Failure of Implant

  MAUDE report 17558507 ↗
• InjuryJun 17, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY, INCREASED SENSITIVITY, INFLAMMATION AND PAIN WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant

  MAUDE report 12020293 ↗
• InjuryMar 29, 2021Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  MOBILITY AND BONE LOSS WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE (ALLOGRAFT) WAS PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 11581043 ↗
• InjuryJan 8, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 11141322 ↗
• InjuryJan 5, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  ASYMPTOMATIC WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 11120766 ↗
• InjuryMay 7, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY AND SWELLING WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Swelling

  MAUDE report 10032720 ↗
• InjuryApr 24, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INADEQUATE BONE QUALITY/ BONE QUANTITY WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE I. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. OSSEOINTEGRATION WAS NOT ACHIEVED.

  Patient problems: Failure of Implant

  MAUDE report 9995512 ↗
• InjuryNov 15, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 9330671 ↗
• InjuryNov 15, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY AND PAIN WERE REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE I. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 9330668 ↗
• InjuryAug 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PAIN, BLEEDING, INFECTION AND MOBILITY WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE I. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Pain; Unspecified Infection

  MAUDE report 8849811 ↗
• InjuryApr 10, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 8498752 ↗
• InjuryNov 28, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BONE QUALITY/BONE "QUANITTY" WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 8110148 ↗
• InjuryJul 23, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  SWELLING AND INADEQUATE BONE QUALITY/BONE QUANTITY WERE REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE III. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS PERFORMED (FREEZE DRIED DEMINERALIZED BONE).

  Patient problems: Failure of Implant; Swelling

  MAUDE report 7710703 ↗
• InjuryNov 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY, PAIN AND BRUXISM WERE REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1 TO 5 YEARS AFTER PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7052805 ↗
• InjuryNov 2, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6996211 ↗
• InjuryOct 16, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PAIN, SWELLING, NUMBNESS, ASINTOMATICA, AND FISTULA WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT TIME OF SURGERY. INADEQUATE BONE QUALITY/BONE QUANTITY WAS REPORTED.

  Patient problems: Failure of Implant; Fistula; Pain; Swelling

  MAUDE report 6951951 ↗
• InjurySep 6, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN, BLEEDING, SWELLING, NUMBNESS AND FISTULA WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED.

  Patient problems: Failure of Implant; Numbness; Pain; Swelling

  MAUDE report 6845029 ↗
• InjuryAug 30, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INFECTION, MOBILITY AND FISTULA WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED.

  Patient problems: Failure of Implant; Fistula; Unspecified Infection

  MAUDE report 6829684 ↗
• InjuryMar 23, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN, SWELLING, BLEEDING, INFECTION AND NUMBNESS WERE REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE I.

  Patient problems: Failure of Implant; Numbness; Pain; Swelling; Unspecified Infection

  MAUDE report 6429868 ↗
• InjuryDec 14, 2016Osseointegration Problem; Osseointegration Problem

  NO OSSEOINTEGRATION OF THE IMPLANT AFTER DISCOVERY BUT BEFORE FINAL RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT SURGERY TYPE IV.

  Patient problems: Failure of Implant

  MAUDE report 6173281 ↗
• InjuryJun 22, 2016Device Issue; Device Issue

  PAIN WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE BETWEEN TYPE II & TYPE III. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PATIENT REQUESTED REMOVAL OF IMPLANT DUE TO PAIN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 5741283 ↗
• InjuryJun 2, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. NO OSSEOINTEGRATION OF THE IMPLANT 1-3 MONTHS AFTER FINAL RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II.

  Patient problems: Failure of Implant

  MAUDE report 5695370 ↗