CAMLOG® PROGRESSIVE-LINE Implant, Promote® plus K1075.4309Recalls & reported problems

ALTATEC GmbH · CAMLOG® PROGRESSIVE-LINE Implant, Promote® plus, screw-mounted, d 4.3 mm, L 9.0 mm · Class 2 · Implant

All models of CAMLOG PROGRESSIVE-LINE Implant, Promote plus (24)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 43
Deaths reported: 0
Injuries reported: 43
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI E219K107543091), received between Mar 22, 2024 and Jun 3, 2026 — classified as 43 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (33 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Use of Device Problem33
Failure to Osseointegrate16
Device Handling Problem1
Use of Incorrect Control/Treatment Settings1

Patient problems

Insufficient Information43

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

InjuryJun 3, 2026Failure to Osseointegrate
IMPLANT FAILED TO OSSEOINTEGRATE.
Patient problems: Insufficient Information
MAUDE report 25381809 ↗
InjuryJun 3, 2026Failure to Osseointegrate
IMPLANT FAILED TO OSSEOINTEGRATE.
Patient problems: Insufficient Information
MAUDE report 25375460 ↗
InjuryMay 15, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS
Patient problems: Insufficient Information
MAUDE report 25185230 ↗
InjuryJan 2, 2026Failure to Osseointegrate
IMPLANT FAILED TO OSSEOINTEGRATE.
Patient problems: Insufficient Information
MAUDE report 23942150 ↗
InjuryDec 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED TO OSSEOINTEGRATE.
Patient problems: Insufficient Information
MAUDE report 23876172 ↗
InjuryDec 10, 2025Use of Device Problem; Failure to Osseointegrate; Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23773660 ↗
InjuryDec 10, 2025Use of Device Problem; Failure to Osseointegrate; Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23773368 ↗
InjuryDec 10, 2025Use of Device Problem; Failure to Osseointegrate; Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23770545 ↗
InjuryNov 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED TO OSSEOINTEGRATE.
Patient problems: Insufficient Information
MAUDE report 23612682 ↗
InjuryNov 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED TO OSSEOINTEGRATE.
Patient problems: Insufficient Information
MAUDE report 23612640 ↗
InjuryOct 15, 2025Use of Device Problem; Failure to Osseointegrate; Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23279451 ↗
InjuryOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED TO OSSEOINTEGRATE.
Patient problems: Insufficient Information
MAUDE report 23278880 ↗
InjuryOct 15, 2025Use of Device Problem; Failure to Osseointegrate; Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23278860 ↗
InjuryJul 30, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22663935 ↗
InjuryJul 30, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22663674 ↗
InjuryJul 30, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22663487 ↗
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 21953887 ↗
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 21953835 ↗
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 21953613 ↗
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 21953570 ↗
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 21949295 ↗
InjuryMay 2, 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 21949279 ↗
InjuryMar 4, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21519006 ↗
InjuryMar 4, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21518779 ↗
InjuryMar 4, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21518056 ↗

Device details

UDI-DI	`E219K107543091`
Brand	CAMLOG® PROGRESSIVE-LINE Implant, Promote® plus
Model	K1075.4309
Company	ALTATEC GmbH
Product code	DZE · Implant, Endosseous, Root-Form
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 22, 2020

Device type (GMDN): Screw endosteal dental implant, two-piece

A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

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All Implant, Endosseous, Root-Form devices →

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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