CAMLOG® SCREW-LINE Implant, Promote® plus K1054.3809Recalls & reported problems
ALTATEC GmbH · K1054.3809 CAMLOG® SCREW-LINE Implant, Promote® plus, d=3.8mm, l=9mm · 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 E219K105438091), received between Mar 18, 2024 and Jun 3, 2026 — classified as 12 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
- Use of Device Problem3
- Use of Incorrect Control/Treatment Settings2
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.
InjuryJun 3, 2026Failure to Osseointegrate
InjuryDec 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 23, 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
InjuryMay 14, 2025Use of Incorrect Control/Treatment Settings; Use of Device Problem; Use of Incorrect Control/Treatment Settings; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22017386 ↗InjuryMay 14, 2025Use of Incorrect Control/Treatment Settings; Use of Device Problem; Use of Incorrect Control/Treatment Settings; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22017339 ↗InjuryMar 18, 2024Use of Device Problem; Failure to Osseointegrate; Use of Device Problem; Failure to Osseointegrate
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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