simply ReActive ImplantRecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 114
- Deaths reported
- 0
- Injuries reported
- 114
- Recalls
- 0
We found 17 models of simply ReActive Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 114 adverse event reports in the FDA's MAUDE database, received between Feb 22, 2019 and Sep 15, 2023 — classified as 114 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (73 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported simply ReActive Implant problems
Device problems
- Failure to Osseointegrate73
- Loss of Osseointegration25
- Osseointegration Problem6
- Positioning Failure5
- Positioning Problem4
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant113
- Osteopenia/ Osteoporosis34
- Inflammation22
- No Consequences Or Impact To Patient22
- Unspecified Infection21
- Fibrosis20
- Pain13
- Granuloma9
simply ReActive Implant models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- simply ReActive® Implant 754710UImplant, Endosseous, Root-Form18 reports
- simply ReActive® Implant 754211UImplant, Endosseous, Root-Form17 reports
- simply ReActive® Implant 753713UImplant, Endosseous, Root-Form13 reports
- simply ReActive® Implant 753711UImplant, Endosseous, Root-Form11 reports
- simply ReActive® Implant 754708UImplant, Endosseous, Root-Form11 reports
- simply ReActive® Implant 755710UImplant, Endosseous, Root-Form8 reports
- simply ReActive® Implant 753710UImplant, Endosseous, Root-Form7 reports
- simply ReActive® Implant 754713UImplant, Endosseous, Root-Form7 reports
- simply ReActive® Implant 754213UImplant, Endosseous, Root-Form5 reports
- simply ReActive® Implant 754711UImplant, Endosseous, Root-Form3 reports
- simply ReActive® Implant 755711UImplant, Endosseous, Root-Form3 reports
- simply ReActive® Implant 755713UImplant, Endosseous, Root-Form3 reports
- simply ReActive® Implant 753708UImplant, Endosseous, Root-Form2 reports
- simply ReActive® Implant 754210UImplant, Endosseous, Root-Form2 reports
- simply ReActive® Implant 754716UImplant, Endosseous, Root-Form2 reports
- simply ReActive® Implant 753716UImplant, Endosseous, Root-Form1 report
- simply ReActive® Implant 755708UImplant, Endosseous, Root-Form1 report
Recent simply ReActive Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 15, 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; Granuloma; Osteopenia/ Osteoporosis
MAUDE report 17758012 ↗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 ↗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; Granuloma; Inflammation; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 16775682 ↗InjuryFeb 28, 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; Osteopenia/ Osteoporosis
MAUDE report 16453715 ↗InjuryJan 24, 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; Osteopenia/ Osteoporosis
MAUDE report 16231156 ↗InjuryDec 29, 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; Pain
MAUDE report 16066541 ↗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 ↗InjuryNov 8, 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 15750961 ↗InjuryNov 8, 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; Osteopenia/ Osteoporosis
MAUDE report 15750959 ↗InjurySep 26, 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; Fibrosis; Numbness; Osteopenia/ Osteoporosis; Sensitivity of Teeth
MAUDE report 15483958 ↗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 8, 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 14955776 ↗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 ↗InjuryJul 4, 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 14906460 ↗InjuryJul 4, 2022Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; Sinus Perforation
MAUDE report 14906457 ↗
Other Implant Direct Sybron Manufacturing LLC products
- Legacy3 Implant75 models · 9,801 reports
- Legacy2 Implant78 models · 8,257 reports · 2 recalls
- simply InterActive Implant23 models · 4,946 reports
- simply Legacy2 Implant38 models · 3,319 reports
- RePlant Implant20 models · 2,351 reports
- SIMPLY ICONIC Implant39 models · 2,189 reports
- Legacy4 Implant58 models · 1,786 reports
- Legacy1 Implant27 models · 1,635 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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