LOCATOR Overdenture Implant System 07455Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant Implant, 2.4mmD x 10mmL, 4mm 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 overdenture implant is a dental implant placed in the jawbone to hold a denture. All 280 reports are injury reports, mostly describing implants that did not bond with the bone, with some describing fractures. Reports fell to 7 in the last 12 months from 20 before. There were no deaths, and 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
- 280
- Deaths reported
- 0
- Injuries reported
- 280
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 280 adverse event reports that list this exact device (DI 00840481101519), received between May 15, 2019 and Aug 25, 2026 — classified as 280 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (137 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 Osseointegrate137
- Loss of Osseointegration137
- Fracture9
Patient problems
- Failure of Implant145
- No Clinical Signs, Symptoms or Conditions101
- Inadequate Osseointegration15
- No Known Impact Or Consequence To Patient9
- Unspecified Infection7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Inflammation4
- No Code Available4
Recent adverse event reports
The 25 most recent of 280 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50440570 ↗InjuryMay 14, 2026Failure to Osseointegrate
InjuryApr 2, 2026Loss of Osseointegration
LOSS OF INTEGRATION AND NO OTHER INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767496 ↗InjuryApr 2, 2026Loss of Osseointegration
LOSS OF INTEGRATION AND NO OTHER INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767493 ↗InjuryJan 29, 2026Failure to Osseointegrate
NON INTEGRATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24217985 ↗InjuryNov 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23458722 ↗InjurySep 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22928122 ↗InjuryJul 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 16, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22215602 ↗InjuryJun 16, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22215585 ↗InjuryJun 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22135369 ↗InjuryJun 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22135368 ↗InjuryJun 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22135366 ↗InjuryJun 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22135365 ↗InjuryJun 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22135364 ↗InjuryMay 27, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22092706 ↗InjuryMay 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22045182 ↗InjuryApr 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21774403 ↗InjuryMar 27, 2025Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration
LOSS OF INTEGRATION AND THE BROKEN TIP WAS COMPLETELY REMOVED ACCORDING TO A PHONE CALL WITH MRS. (B)(6) ON (B)(6)2025. AN OPG AFTER THIS PROCEDURE COULD NOT BE MADE DUE TO THE LIMITED MOBILITY OF THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21714391 ↗InjuryMar 27, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21714276 ↗InjuryMar 26, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION. THE IMPLANT NO LONGER FIXED IN THE BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21701897 ↗InjuryFeb 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. THE IMPLANT DID NOT INTEGRATE INTO THE BONE IMPLANT AND FAILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21460252 ↗
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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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