CAMLOG® SCREW-LINE Implant, Promote® plus K1054.3311Recalls & reported problems
ALTATEC GmbH · K1054.3311 SCREW-LINE Implant, Promote® plus d 3.3 L 11 · Class 2 · Implant
All models of CAMLOG SCREW-LINE Implant, Promote plus (60)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI E219K105433111), received between May 30, 2024 and Apr 30, 2026 — classified as 10 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (10 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate10
Patient problems
- Insufficient Information10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2026Failure to Osseointegrate
InjurySep 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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