RePlus® Implant 703711Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · 3.7mmD x 11.5mmL, 3.5mmD Platform · Class 2 · Implant
All models of RePlus Implant (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10841307104209), received between Sep 6, 2019 and Aug 2, 2022 — classified as 11 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (8 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.
Most reported problems
Device problems
- Loss of Osseointegration8
- Adverse Event Without Identified Device or Use Problem1
- Failure to Osseointegrate1
- Positioning Problem1
Patient problems
- Failure of Implant11
- Osteopenia/ Osteoporosis5
- Unspecified Infection4
- Inflammation3
- No Consequences Or Impact To Patient1
- Pain1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryAug 2, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT 83328, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis
MAUDE report 15146459 ↗InjuryApr 27, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 14219623 ↗InjuryFeb 15, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 13539416 ↗InjuryJan 31, 2022Loss 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 13397481 ↗InjuryJun 4, 2021Positioning Problem; Positioning Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PRODUCT FIT WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 11937237 ↗InjuryJun 3, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 11927373 ↗InjuryJan 28, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 11247192 ↗InjuryNov 24, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 10895946 ↗InjuryJan 22, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 9614650 ↗InjuryNov 21, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 9351905 ↗InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS PER COMPLAINT (B)(4), A DENTAL IMPLANT WAS NO LONGER APPROPRIATE DUE TO FURTHER TOOTH LOSS AND THE IMPLANT WAS REMOVED. NO PATIENT EFFECT WAS REPORTED.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8972233 ↗
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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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