TRICAM Dental Implant System 305010Recalls & reported problems
Ace Surgical Supply CO., Inc. · TRICAM 5.0X10MM 5HD INTERNAL IMPLANT 6Al-4V ELI NOBEL CLONE · Class 2 · Implant
All models of TRICAM Dental Implant System (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This TRICAM dental implant replaces a missing tooth root. The 84 reports mostly describe implants that never fused with the jawbone or came loose, along with pain, infection and swelling. There are 84 injury reports and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 84
- Deaths reported
- 0
- Injuries reported
- 84
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00614950005277), received between Dec 1, 2015 and May 18, 2026 — classified as 84 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (57 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.
Reports received per month
Most reported problems
Device problems
- Osseointegration Problem57
- Failure to Osseointegrate49
- Insufficient Device Problem Information11
- Loss of Osseointegration2
- Appropriate Device Problem Term/Code Not Available1
- Patient Device Interaction Problem1
- Unintended Movement1
Patient problems
- Failure of Implant83
- Pain13
- Unspecified Infection12
- Swelling7
- Fistula5
- Insufficient Information1
- Numbness1
Recent adverse event reports
The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2026Failure to Osseointegrate
InjurySep 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED THE DAY OF IMPRESSIONS FOR CROWN.
Patient problems: Failure of Implant
MAUDE report 20334171 ↗InjuryMar 18, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 4, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryAug 4, 2023Osseointegration Problem; Osseointegration Problem
InjuryJul 13, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryApr 11, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CONSUMER REPORTED THAT THE PATIENT HAD A TOOTH TYPE OF 2, THE CONSUMER ALSO REPORTED THAT THE TIME OF LOSS IN RELATION TO IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION, PRIMARY STABILITY & OSSEOINTEGRATION WAS ACHIEVED.
Patient problems: Failure of Implant
MAUDE report 16714284 ↗InjuryDec 13, 2021Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY WAS ACHIEVED. MOBILITY WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS IV. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. OSSEOINTEGRATION WAS NOT ACHIEVED.
Patient problems: Failure of Implant
MAUDE report 12984634 ↗InjuryAug 30, 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 12388134 ↗InjuryAug 27, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PERI-IMPLANTITIS AND MOBILITY WERE 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 (ALLOOSS) WAS PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 12378273 ↗InjuryJul 21, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
PAIN 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. AUGMENTATION PROCEDURE (OSSEOUS) WAS PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 12201849 ↗InjuryApr 22, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
MOBILITY AND INADEQUATE BONE QUALITY WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE IV. 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 11711815 ↗InjuryNov 3, 2020Unintended Movement; Unintended Movement
MOBILITY 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 ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS A SMOKER.
Patient problems: Failure of Implant
MAUDE report 10777427 ↗InjurySep 23, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
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 (VITOSS GRAFT) WAS PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 10574456 ↗InjuryApr 24, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
PERI-IMPLANTITIS, INFECTION, POOR ORAL HYGIENE, PAIN, NUMBNESS AND ASYMPTOMATIC 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. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS A SMOKER.
Patient problems: Failure of Implant; Numbness; Pain; Unspecified Infection
MAUDE report 9995511 ↗InjuryNov 18, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. INADEQUATE BONE QUALITY/BONE QUANTITY WERE REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant
MAUDE report 9335299 ↗InjuryOct 3, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PAIN 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 DIABETES AND IS A SMOKER.
Patient problems: Failure of Implant; Pain
MAUDE report 9151104 ↗InjuryJul 24, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
BONE WAS TOO SOFT, ASYMPTOMATIC AND INADEQUATE BONE QUALITY/BONE QUANTITY 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.
Patient problems: Failure of Implant
MAUDE report 8820978 ↗InjuryMay 24, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS 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 8641622 ↗InjuryMay 6, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
INADEQUATE BONE QUALITY/BONE QUANTITY WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS 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 problems: Failure of Implant
MAUDE report 8583912 ↗InjuryApr 10, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
INFECTION, FISTULA AND PERI-IMPLANTITIS WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1 TO 5 YEARS AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT TIME OF SURGERY.
Patient problems: Failure of Implant; Fistula; Unspecified Infection
MAUDE report 8498770 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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