Legacy™2 Implant 827006Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø7.0 x 6 Platform 5.7mmD · Implant
All models of Legacy2 Implant (78)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10841307101536), received between Aug 30, 2019 and Dec 12, 2024 — classified as 12 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (6 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 Osseointegrate6
- Loss of Osseointegration2
- Fracture1
- Malposition of Device1
- Osseointegration Problem1
- Positioning Problem1
- Separation Failure1
Patient problems
- Failure of Implant11
- Unspecified Infection4
- No Clinical Signs, Symptoms or Conditions2
- Pain2
- Inadequate Osseointegration1
- Inflammation1
- No Consequences Or Impact To Patient1
- Osteopenia/ Osteoporosis1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2024Malposition of Device; Malposition of Device
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20919287 ↗InjuryOct 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20444597 ↗MalfunctionFeb 3, 2023Separation Failure; Separation Failure
PER COMPLAINT (B)(4), BEFORE CLINICAL PROCEDURE, COMPONENTS COULD NOT BE SEPARATED.
Patient problems: Failure of Implant
MAUDE report 16288914 ↗InjuryNov 28, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 15874844 ↗InjuryOct 18, 2022Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain
MAUDE report 15626910 ↗InjuryJun 30, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 14875263 ↗InjuryApr 20, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED IMPLANT FRACTURE AT OR AFTER DELIVERY OF PROSTHETIC RESTORATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 11694175 ↗InjuryMar 17, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE
Patient problems: Failure of Implant
MAUDE report 11503291 ↗InjuryDec 24, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 11071035 ↗InjuryAug 5, 2020Positioning Problem; Positioning Problem
AS PER COMPLAINT (B)(4) DURING A CLINICAL PROCEDURE A DENTAL IMPLANT DISPLAYED A LACK OF PRIMARY STABILITY AND THE IMPLANT WAS REMOVED. THERE WAS 1 PATIENT INVLOVED IN THIS EVENT.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 10367951 ↗InjuryFeb 7, 2020Loss of Osseointegration; Loss of Osseointegration
(B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 9680228 ↗InjuryDec 10, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 9443298 ↗InjuryAug 30, 2019Fracture; Fracture
AS PER COMPLAINT (B)(4); AFTER THE CLINICAL PROCEDURE (AFTER IMPLANT PLACEMENT) IT WAS OBSERVED THAT THE IMPLANT FRACTURED AND THE IMPLANT WAS REMOVED.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 8952291 ↗
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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