TRICAM Dental Implant System 305013Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00614950005291), received between Dec 22, 2015 and Feb 7, 2024 — classified as 23 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (17 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2024Failure to Osseointegrate; Patient-Device Incompatibility; Failure to Osseointegrate; Patient-Device Incompatibility

  SAME DAY SPINNER.

  Patient problems: Failure of Implant

  MAUDE report 18664289 ↗
• InjuryOct 5, 2023Loss of Osseointegration; Loss of Osseointegration

  PT HAD IMPLANT RETAINED DENTURE - RECENTLY DEVELOPED MOBILITY - IMPLANT REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 17882425 ↗
• InjuryJun 21, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INADEQUATE BONE QUALITY/BONE QUANTITY AND PAIN 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 WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 12035199 ↗
• InjuryApr 12, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  ASYMPTOMATIC 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 WA ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE (VITOSS) WAS PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 11648037 ↗
• InjuryFeb 25, 2021Failure 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 11377564 ↗
• InjuryFeb 4, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  ASYMPTOMATIC, POOR ORAL HYGIENE AND INADEQUATE BONE QUALITY/BONE QUANTITY WEE 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 WAS PERFORMED AT THE TIME OF SURGERY. PATIENT HAS ALLERGIES (PCN).

  Patient problems: Failure of Implant

  MAUDE report 11282507 ↗
• InjuryNov 16, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 10842654 ↗
• InjuryOct 24, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. MOBILITY AND ASYMPTOMATIC WERE REPORTED. 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 9232358 ↗
• InjuryAug 1, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY AND PERI-IMPLANTITIS 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 8849812 ↗
• InjuryJun 27, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  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 8738618 ↗
• InjuryApr 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY, PERI-IMPLANTITIS AND PAIN WERE REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR AFTER PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE I. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE (BONE GRAFT) WAS PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7436145 ↗
• InjuryFeb 26, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY AND ASYMPTOMATIC WERE REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE II. 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 7295598 ↗
• InjuryDec 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY, INFECTION, PERI-IMPLANTITIS, ASINTOMATICA 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 ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT HAS XEROSTOMIA.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 7135225 ↗
• InjuryNov 13, 2017Failure 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 III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED.

  Patient problems: Failure of Implant

  MAUDE report 7024649 ↗
• InjuryNov 13, 2017Failure 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 III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED.

  Patient problems: Failure of Implant

  MAUDE report 7024647 ↗
• InjurySep 5, 2017Osseointegration Problem; Osseointegration Problem

  ASYMPTOMATIC 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 HAS DIABETES MELLITUS.

  Patient problems: Failure of Implant

  MAUDE report 6843458 ↗
• InjuryApr 24, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  OSSEOINTEGRATION WAS NOT ACHIEVED. BONE QUALITY AT TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION.

  Patient problems: Failure of Implant

  MAUDE report 6516595 ↗
• InjuryApr 24, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  OSSEOINTEGRATION WAS NOT ACHIEVED. BONE QUALITY AT TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION.

  Patient problems: Failure of Implant

  MAUDE report 6516563 ↗
• InjuryMar 24, 2017Osseointegration Problem; Osseointegration Problem

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

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

  MAUDE report 6432564 ↗
• InjuryFeb 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY AND INFECTION 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 AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION WAS PERFORMED AT TIME OF SURGERY.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 6360674 ↗
• InjuryOct 28, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY AND PAIN WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6063940 ↗
• InjuryApr 8, 2016Osseointegration Problem; Osseointegration Problem

  ASYMPTOMATIC WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE RESTORATION. PRIMARY STABILITY WAS ACHIEVED BUT OSSEOINTEGRATION WAS NOT. AUGMENTATION PROCEDURE WAS PERFORMED AT THE TIME OF SURGERY. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE II. IT WAS REPORTED IMPLANT CAME OUT WHEN WENT TO UNCOVER.

  Patient problems: Failure of Implant

  MAUDE report 5564120 ↗
• InjuryDec 22, 2015Failure to Osseointegrate

  MOBILITY WAS REPORTED AT THE TIME OF IMPLANT FAILURE.

  Patient problems: Failure of Implant

  MAUDE report 5319904 ↗