CAMLOG® SCREW-LINE Implant, Promote® plus K1056.3813Recalls & reported problems
ALTATEC GmbH · CAMLOG® SCREW-LINE Implant, Promote® plus, snap-in, d 3.8 mm, l 13 mm · 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
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI E219K105638131), received between Mar 5, 2024 and May 8, 2026 — classified as 20 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (15 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 Osseointegrate15
- Use of Device Problem5
Patient problems
- Insufficient Information20
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryMay 8, 2026Failure to Osseointegrate
InjuryMay 6, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25094710 ↗InjuryApr 9, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24830663 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 30, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21933501 ↗InjuryApr 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 10, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21131657 ↗InjuryDec 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 1, 2024Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 19642869 ↗InjuryJun 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 15, 2024Failure 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-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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