CAMLOG® SCREW-LINE Implant, Promote® K1045.3809Recalls & reported problems
ALTATEC GmbH · K1045.3809 CAMLOG® SCREW-LINE Implant, Promote®, screw-mounted, d 3.8, L 9 · Class 2 · Implant
All models of CAMLOG SCREW-LINE Implant, Promote (30)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI E219K104538091), received between Feb 24, 2024 and Oct 16, 2025 — classified as 8 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate7
- Use of Device Problem2
Patient problems
- Insufficient Information8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 15, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22819310 ↗InjuryMay 30, 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 22115879 ↗InjuryNov 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
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- 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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