LOCATOR Overdenture Implant System 07386Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant, 2.9mmD x 10mmL · Class 2 · Implant
All models of LOCATOR Overdenture Implant System (74)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840481129643), received between Nov 8, 2021 and Jul 12, 2024 — classified as 9 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (7 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 Osseointegrate7
- Loss of Osseointegration2
Patient problems
- Failure of Implant5
- No Clinical Signs, Symptoms or Conditions4
- Pain1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJul 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 3, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16865388 ↗InjuryFeb 9, 2023Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. FAILURE TO INTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16334809 ↗InjurySep 1, 2022Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION. LOOSE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15341952 ↗InjuryMar 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION REPORTED. IMPLANT PLACED (B)(6) 2021 AND IMPLANT #4 FAILED.
Patient problems: Failure of Implant
MAUDE report 13691102 ↗InjuryDec 22, 2021Failure to Osseointegrate; Failure to Osseointegrate
NON- INTEGRATION. IMPLANT WAS PLACED (B)(6) 2021 ALONG WITH 4 ADDITIONAL IMPLANTS FOR IMPLANT SUPPORTED UPPER DENTURE. REMOVED (B)(6) 2021.
Patient problems: Failure of Implant
MAUDE report 13064072 ↗InjuryNov 8, 2021Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. 5 LODI IMPLANTS WERE PLACED (B)(6) 2021, LOCATOR ABUTMENT PLACED (B)(6) 2021, SNAP IN DENTURE DELIVERED (B)(6) 2021. 2 IMPLANTS LOOSE (B)(6) 2021.
Patient problems: Failure of Implant
MAUDE report 12775367 ↗InjuryNov 8, 2021Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. 5 LODI IMPLANTS WERE PLACED (B)(6) 2021, LOCATOR ABUTMENT PLACED (B)(6) 2021, SNAP IN DENTURE DELIVERED (B)(6) 2021. 2 IMPLANTS LOOSE (B)(6) 2021.
Patient problems: Failure of Implant
MAUDE report 12775349 ↗InjuryNov 8, 2021Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. IMPLANT PLACED TO REPLACE PREVIOUS FAILED IMPLANT (B)(6) 2021. PATIENT REPORTED PAIN (B)(6) 2021. CLEANING APPOINTMENT (B)(6) 2021 IMPLANT REMOVED.
Patient problems: Failure of Implant; Pain
MAUDE report 12775182 ↗
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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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