TRICAM Dental Implant System 304316Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00614950005253), received between Nov 24, 2015 and Jun 21, 2021 — classified as 10 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY WAS 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 12035157 ↗
• InjuryApr 24, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN, BLEEDING, SWELLING, NUMBNESS, INFECTION AND FISTULA WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR AFTER PROSTHETIC RESTORATION. OSSEOINTEGRATION WAS NOT ACHIEVED. PATIENT IS A SMOKER.

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

  MAUDE report 9995500 ↗
• InjuryApr 24, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INFECTION, POOR ORAL HYGIENE, NUMBNESS AND ASYMPTOMATIC WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant; Numbness; Unspecified Infection

  MAUDE report 9995497 ↗
• InjuryApr 24, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  NUMBNESS AND MOBILITY WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. PATIENT HAS AN UNCONTROLLED ENDOCRINE DISEASE.

  Patient problems: Failure of Implant; Numbness

  MAUDE report 9995491 ↗
• InjuryMay 10, 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 AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 8601617 ↗
• InjuryApr 27, 2017Missing Value Reason; Missing Value Reason

  BLEEDING AND ASYMPTOMATIC WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. PATIENT IS ALLERGIC TO AMOXICILLIN.

  Patient problems: Failure of Implant

  MAUDE report 6525501 ↗
• InjuryNov 28, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY AND BONE LOSS WAS REPORTED. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. NO OSSEOINTEGRATION OF THE IMPLANT 6 MONTHS AFTER FINAL RESTORATION.

  Patient problems: Failure of Implant

  MAUDE report 6130043 ↗
• InjuryMar 1, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. NO OSSEOINTEGRATION WITHIN 3-6 MONTHS.

  Patient problems: Failure of Implant

  MAUDE report 5471792 ↗
• InjuryDec 22, 2015Failure to Osseointegrate

  INFECTION WAS REPORTED AT THE TIME OF IMPLANT FAILURE. TIME OF LOSS WAS 0-1 MONTHS BEFORE PROSTHETIC RESTORATION.

  Patient problems: Failure of Implant

  MAUDE report 5319939 ↗
• InjuryNov 24, 2015Osseointegration Problem

  INFECTION AND MOBILITY WAS REPORTED AT THE TIME OF IMPLANT FAILURE. PRIMARY STABILITY WAS ACHIEVED. NO AUGMENTATION WAS PERFORMED AT THE TIME OF SURGERY. BONE QUALITY AT TIME OF FAILURE WAS REPORTED AS TYPE II.

  Patient problems: Failure of Implant

  MAUDE report 5247563 ↗