Legacy™ SMARTbase, Narrow 8735-80NRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841307122739), received between Mar 24, 2020 and Mar 30, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
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
- Device Markings/Labelling Problem1
- Missing Information1
Patient problems
- Failure of Implant1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
PER COMPLAINT (B)(4), BEFORE CLINICAL PROCEDURE, LABELING ISSUE WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 16646463 ↗MalfunctionMar 24, 2020Missing Information; Missing Information
PER COMPLAINT (B)(4), DURING AN INTERNAL REVIEW, A PART WAS IDENTIFIED AS MISSING A LABEL.
Patient problems: No Patient Involvement
MAUDE report 9873308 ↗
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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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