Blossom S3413Recalls & reported problems
Intra-Lock International, Inc. · Gs Blossom™ Implant Ø3.4 x 13mm + Cover Screw · Class 2 · Implant
All models of Blossom (66)
Data updated Oct 16, 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 D742S34130), received between Apr 4, 2024 and Feb 26, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (7 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 Osseointegrate7
Patient problems
- Insufficient Information7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2026Failure to Osseointegrate
InjuryApr 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 14, 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
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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