CAMLOG® SCREW-LINE Implant, Promote® plus K1054.3811Recalls & reported problems
ALTATEC GmbH · K1054.3811 CAMLOG® SCREW-LINE Implant, Promote® plus, d=3.8mm, l=11mm · 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
- 12
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI E219K105438111), received between Mar 5, 2024 and Nov 12, 2025 — classified as 12 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (11 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 Osseointegrate11
- Fracture1
- Use of Device Problem1
Patient problems
- Insufficient Information12
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 12, 2025Fracture; Fracture
InjuryNov 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 19, 2025Use of Device Problem; Failure to Osseointegrate; Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23096246 ↗InjuryAug 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 5, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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