CAMLOG® SCREW-LINE Implant, Promote® plus K1056.3811Recalls & reported problems
ALTATEC GmbH · CAMLOG® SCREW-LINE Implant, Promote® plus, snap-in, d 3.8 mm, l 11 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
Quick summary
This is a CAMLOG Promote plus dental implant, a screw-shaped implant used as a root replacement in the jaw. The 38 reports mostly describe implants that failed to fuse with the surrounding bone, and in several cases the implant was removed shortly after surgery because of healing concerns. All 38 reports involve injuries, no deaths are reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI E219K105638111), received between Mar 5, 2024 and May 26, 2026 — classified as 38 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (26 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 Osseointegrate26
- Use of Device Problem14
Patient problems
- Insufficient Information38
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25276234 ↗InjuryMay 5, 2026Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25083304 ↗InjuryApr 23, 2026Failure to Osseointegrate
InjuryApr 22, 2026Failure to Osseointegrate
InjuryApr 20, 2026Failure to Osseointegrate
InjuryDec 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 4, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23463387 ↗InjuryAug 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 4, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22143429 ↗InjuryMay 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 28, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22099644 ↗InjuryMay 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 1, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21941559 ↗InjuryFeb 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 9, 2025Use of Device Problem; Failure to Osseointegrate; Use of Device Problem; Failure to Osseointegrate
InjuryDec 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 11, 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 20428247 ↗InjuryOct 10, 2024Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 20424571 ↗InjurySep 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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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