simply ReActive® Implant 754708URecalls & reported problems
Implant Direct Sybron Manufacturing LLC · 4.7mmD x 8mmL, 4.3mmD Platform · Class 2 · Implant
All models of simply ReActive Implant (17)
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 10841307108139), received between Aug 21, 2019 and Apr 20, 2023 — classified as 11 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (9 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
- Failure to Osseointegrate9
- Loss of Osseointegration2
Patient problems
- Failure of Implant11
- No Consequences Or Impact To Patient5
- Inflammation3
- Osteopenia/ Osteoporosis3
- Unspecified Infection2
- Fibrosis1
- Hyperplasia1
- Pain1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryApr 20, 2023Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 16775685 ↗InjuryNov 24, 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; Fibrosis; Osteopenia/ Osteoporosis
MAUDE report 15860394 ↗InjuryDec 14, 2021Failure 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; Osteopenia/ Osteoporosis
MAUDE report 13006927 ↗InjuryFeb 25, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9749014 ↗InjuryFeb 14, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Hyperplasia
MAUDE report 9710655 ↗InjurySep 13, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE DUE TO INFECTION.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 9022366 ↗InjurySep 11, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, IT WAS OBSERVED THAT PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8987263 ↗InjurySep 11, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED FAILURE OR LOSS OF IMPLANT TO INTEGRATE AND IMPLANT WAS REMOVED.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8987109 ↗InjurySep 9, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), IMPLANT FAILED TO INTEGRATE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8977956 ↗InjurySep 9, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), IMPLANT FAILED TO INTEGRATE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8977953 ↗InjuryAug 21, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT HAD EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE. PATIENT REPORTED WITH LOOSE IMPLANT AND IMPLANT WAS PULLED OUT BY THE PATIENT.
Patient problems: Failure of Implant; Pain
MAUDE report 8914101 ↗
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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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