LOCATOR Overdenture Implant System 07461Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant, 2.9mmD x 12mmL, 2.5mm Cuff · Class 2 · Implant
All models of LOCATOR Overdenture Implant System (74)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This LOCATOR dental implant is a screw placed in the jawbone to hold a denture. The 359 reports mostly describe implants that failed to bond with the bone, with some patients reporting swelling and gum infection around the implant. The reports record 359 injuries and no deaths. Reports fell from 24 in the year before to 11 in the last year. 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
- 359
- Deaths reported
- 0
- Injuries reported
- 359
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 359 adverse event reports that list this exact device (DI 00840481101557), received between May 15, 2019 and Jul 27, 2026 — classified as 359 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (184 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
- Failure to Osseointegrate184
- Loss of Osseointegration172
- Fracture8
Patient problems
- Failure of Implant182
- No Clinical Signs, Symptoms or Conditions123
- Inadequate Osseointegration20
- No Known Impact Or Consequence To Patient14
- Unspecified Infection12
- No Code Available9
- Pain7
- Insufficient Information5
Recent adverse event reports
The 25 most recent of 359 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Failure to Osseointegrate
NON INTEGRATION.patient walked into the office with the implant in their hand, his body rejected the implant, and there was no integration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50047734 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of integration and no other information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50047725 ↗InjuryJun 2, 2026Loss of Osseointegration
DOCTOR REPORTED LOSS OF INTEGRATION. LOSS OF INTEGRATION AFTER 10 YEARS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364067 ↗InjuryJun 2, 2026Loss of Osseointegration
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 24 LOST INTEGRATION AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364066 ↗InjuryMay 19, 2026Loss of Osseointegration
Doctor reported loss of integration, swelling and peri-implantitis at tooth site 24. LOSS of integration after 10 years.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25222897 ↗InjuryMay 19, 2026Loss of Osseointegration
Doctor reported loss of integration, swelling and peri-implantitis at tooth site 22. LOSS of integration after 10 years.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25222895 ↗InjuryMay 7, 2026Failure to Osseointegrate
NON-INTEGRATION NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117352 ↗InjuryMar 12, 2026Loss of Osseointegration
LOSS OF INTEGRATION AND NO OTHER INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24586276 ↗InjuryMar 3, 2026Loss of Osseointegration
LOSS OF INTEGRATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24499285 ↗InjuryMar 3, 2026Loss of Osseointegration
LOSS OF INTEGRATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24499281 ↗InjuryNov 14, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23556942 ↗InjurySep 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 14, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION. IT WAS REPORTED THAT THE IMPLANT LOST INTEGRATION AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22806440 ↗InjuryAug 14, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION. IT WAS REPORTED THAT THE IMPLANT LOST INTEGRATION AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22806439 ↗InjuryApr 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21904992 ↗InjuryApr 2, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21755177 ↗InjuryApr 2, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21755031 ↗InjuryMar 27, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21714387 ↗InjuryMar 27, 2025Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration
LOSS OF INTEGRATION AND IMPLANT WAS BROKEN AND REMAINED IN THE BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21714386 ↗InjuryMar 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 26, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION. NO INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21472757 ↗InjuryFeb 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. IT WAS REPORTED THAT THE IMPLANTS FAILED TO INTEGRATE AND WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21460254 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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