Blossom S4011 (UDI D742S40110)Recalls & reported problems
Intra-Lock International, Inc. · Gs Blossom™ Implant Ø4.0 x 11.5mm + Cover Screw · Class 2 · Implant
All models of Blossom (66)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI D742S40110), received between Apr 4, 2024 and Oct 31, 2024 — classified as 5 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (5 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 Osseointegrate5
Patient problems
- Insufficient Information5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryOct 31, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 31, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 31, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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