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Legacy™ Implant Open-Tray Transfer 8045-08Recalls & reported problems

Implant Direct Sybron Manufacturing LLC · Class 1 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841307121534), received between Jul 12, 2019 and Jul 25, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Positioning Failure” (1 report).

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

Device problems

  • Positioning Failure1
  • Separation Failure1

Patient problems

  • Failure of Implant2
  • Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 25, 2022Positioning Failure; Positioning Failure

    PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

    Patient problems: Failure of Implant

    MAUDE report 15093347 ↗
  • InjuryJul 12, 2019Separation Failure; Separation Failure

    PER COMPLAINT (B)(4), AN IMPRESSION COPING WOULD NOT UNSCREW FROM A DENTAL IMPLANT WHILE CROWN IMPRESSIONS WERE BEING TAKEN. THE IMPLANT WAS BACKED OUT. THE PATIENT EXPERIENCED PAIN.

    Patient problems: Failure of Implant; Pain

    MAUDE report 8786970 ↗

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Sources and updates

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