TRICAM Dental Implant System 303516Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00614950005208), received between Feb 10, 2016 and Apr 24, 2020 — classified as 15 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  SWELLING, PAIN, NUMBNESS, FISTULA AND MOBILITY 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 AND OSSEOINTEGRATION WAS NOT ACHIEVED. PATIENT HAS DIABETES.

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

  MAUDE report 9995504 ↗
• InjuryNov 18, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PAIN, SWELLING, NUMBNESS, FISTULA AND INADEQUATE BONE QUALITY/BONE QUANTITY WERE REPORTED. 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; Fistula; Numbness; Pain; Swelling

  MAUDE report 9335312 ↗
• InjuryOct 3, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BONE QUALITY ATT HE TIME OF IMPLANT FAILURE TYPE II. MOBILITY AND POOR ORAL HYGIENE WERE REPORTED. 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 HAS XEROSTOMIA AND IS A SMOKER.

  Patient problems: Failure of Implant

  MAUDE report 9151118 ↗
• InjuryMay 6, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

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

  Patient problems: Failure of Implant

  MAUDE report 8584256 ↗
• InjuryOct 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT HAS DIABETES AND IS A SMOKER.

  Patient problems: Failure of Implant

  MAUDE report 7983338 ↗
• InjuryDec 5, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INADEQUATE BONE QUALITY/BONE QUANTITY 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 PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 7082155 ↗
• InjuryNov 8, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  ASSINTOMATICA 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 7011690 ↗
• InjuryNov 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE I. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 7011684 ↗
• InjurySep 29, 2017Osseointegration Problem; Osseointegration Problem

  MOBILITY AND COULD NOT GET PRIMARY STABILIZATION WERE REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE IV. PRIMARY STABILITY WAS NOT ACHIEVED.

  Patient problems: Failure of Implant

  MAUDE report 6904180 ↗
• InjuryAug 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Failure of Implant

  MAUDE report 6829722 ↗
• InjuryMar 3, 2017Osseointegration Problem; Osseointegration Problem

  PAIN, SWELLING, MOBILITY, INFECTION 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 AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION WAS PERFORMED AT TIME OF SURGERY. ALSO REPORTED THE PATIENT HAS HYPERTENSION AND STEVEN JOHNSON SYNDROME.

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

  MAUDE report 6375902 ↗
• InjuryJan 12, 2017Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THE IMPLANT UNSCREWED AT IMPRESSION STAGE. ASYMPTOMATIC WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANT BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II.

  Patient problems: Failure of Implant

  MAUDE report 6245766 ↗
• InjuryApr 11, 2016Osseointegration Problem; Osseointegration Problem

  PAIN WAS REPORTED. NO OSSEOINTEGRATION OF THE IMPLANT 1-3 MONTHS BEFORE DISCOVERING.

  Patient problems: Failure of Implant

  MAUDE report 5567427 ↗
• InjuryMar 28, 2016Osseointegration Problem; Osseointegration Problem

  INFECTION WAS REPORTED. NO OSSEOINTEGRATION OF IMPLANT 1-3 MONTHS.

  Patient problems: Failure of Implant

  MAUDE report 5528836 ↗
• InjuryFeb 10, 2016Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. TIME OF LOSS IN RELATION TO THE IMPLANT WAS BEFORE RESTORATION. BLEEDING WAS ALSO REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE II. IMPLANT NEVER FUSED TO THE BONE. IT PULLED OUT WHEN TRYING TO REMOVE THE SCREW.

  Patient problems: Failure of Implant

  MAUDE report 5427308 ↗