ReActive® Implant 754716Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.7 x 8 Platform 3.5mmD · Class 2 · Implant
All models of ReActive Implant (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10841307103721), received between Jan 24, 2020 and Jun 10, 2026 — classified as 8 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate8
Patient problems
- Failure of Implant7
- Insufficient Information2
- No Consequences Or Impact To Patient2
- Unspecified Infection2
- Fibrosis1
- Inadequate Osseointegration1
- Osteopenia/ Osteoporosis1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25462083 ↗InjuryNov 2, 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; Insufficient Information
MAUDE report 15716164 ↗InjuryOct 25, 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; Insufficient Information
MAUDE report 12688840 ↗InjuryJul 8, 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; Osteopenia/ Osteoporosis
MAUDE report 12134731 ↗InjuryJan 25, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 11223014 ↗InjuryAug 6, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), IMPLANT FAILED TO INTEGRATE. PATIENT EXPERIENCED FIBROUS TISSUE.
Patient problems: Failure of Implant; Fibrosis
MAUDE report 10376884 ↗InjuryJan 24, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9626618 ↗InjuryJan 24, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9626616 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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