CAMLOG® SCREW-LINE Implant, Promote® plus K1056.4309Recalls & reported problems
ALTATEC GmbH · CAMLOG® SCREW-LINE Implant, Promote® plus, snap-in, d 4.3 mm, l 9.0 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 CAMLOG SCREW-LINE implant is an endosseous root-form implant. Reports mostly describe the implant failing to integrate with bone, with 41 reports mentioning 41 injuries and no deaths. No recalls name this device. Report counts dropped from 18 to 9 over the last 12 months.
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
- 41
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI E219K105643091), received between Feb 29, 2024 and Jun 2, 2026 — classified as 41 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (34 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 Osseointegrate34
- Use of Device Problem7
- Device Handling Problem1
- Fracture1
Patient problems
- Insufficient Information41
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2026Failure to Osseointegrate
InjuryMay 20, 2026Failure to Osseointegrate
InjuryMay 18, 2026Failure to Osseointegrate
InjuryApr 23, 2026Failure to Osseointegrate
InjuryApr 23, 2026Failure to Osseointegrate
InjuryApr 21, 2026Failure to Osseointegrate
InjuryDec 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 17, 2025Fracture; Fracture
InjuryDec 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 28, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22912848 ↗InjuryAug 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 2, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21954219 ↗InjuryApr 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 25, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21459906 ↗InjuryFeb 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 23, 2025Failure 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.
How reports and recalls are matched · Editorial policy · Report an error on this page