CAMLOG® SCREW-LINE Implant, Promote® plus K1055.4311Recalls & reported problems
ALTATEC GmbH · K1055.4311 CAMLOG® SCREW-LINE Implant, Promote® plus, screw-mounted, d 4.3, 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
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI E219K105543111), received between Mar 5, 2024 and Jun 3, 2026 — classified as 17 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (13 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 Osseointegrate13
- Use of Device Problem4
Patient problems
- Insufficient Information17
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryJun 3, 2026Failure to Osseointegrate
InjuryMay 28, 2026Failure to Osseointegrate
InjuryOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 11, 2024Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 20427432 ↗InjurySep 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 23, 2024Use of Device Problem; Use of Device Problem
IMPLANT REMOVED, DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 20055888 ↗InjuryAug 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 18, 2024Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 19563852 ↗InjuryMay 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 8, 2024Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 19269233 ↗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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