simply ReActive® Implant 754713URecalls & reported problems
Implant Direct Sybron Manufacturing LLC · 4.7mmD x 13mmL, 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
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10841307108160), received between Sep 10, 2019 and Aug 12, 2022 — classified as 7 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (4 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 Osseointegrate4
- Loss of Osseointegration2
- Positioning Problem1
Patient problems
- Failure of Implant7
- Osteopenia/ Osteoporosis3
- Bone Fracture(s)1
- Fibrosis1
- Inflammation1
- No Consequences Or Impact To Patient1
- Organ Dehiscence1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 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; Osteopenia/ Osteoporosis
MAUDE report 15218036 ↗InjuryJul 5, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 14915647 ↗InjuryJun 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 14842371 ↗InjuryMay 20, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Bone Fracture(s); Failure of Implant; Wound Dehiscence
MAUDE report 14461894 ↗InjuryDec 27, 2019Positioning Problem; Positioning Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Organ Dehiscence
MAUDE report 9522926 ↗InjuryOct 11, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Fibrosis; Inflammation
MAUDE report 9178103 ↗InjurySep 10, 2019Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), DURING THE TIME OF EXTRACTION, PATIENT EXPERIENCED FAILURE OR LOSS OF IMPLANT TO INTEGRATE WITH BONE LOSS AROUND THE IMPLANT.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient; Osteopenia/ Osteoporosis
MAUDE report 8979652 ↗
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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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