MIS LANCE EF5-11375Recalls & reported problems

MIS Implants Technologies Ltd. · Lance external hex. implant dia. 3.75 L 11.50mm · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This MIS Lance dental implant is placed in the jaw to replace a tooth root. The 26 reports mainly describe the implant failing to bond with the jawbone and being lost; there were no deaths and 26 injuries. No recalls name this device, and reports fell from 9 in the previous 12 months to 3 in the most recent 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: 26
Deaths reported: 0
Injuries reported: 26
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07290108991963), received between Aug 8, 2024 and Aug 4, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (16 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Osseointegration Problem16
Failure to Osseointegrate10

Patient problems

Failure of Implant26

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

InjuryAug 4, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50132125 ↗
InjuryApr 20, 2026Failure to Osseointegrate
CUSTOMER REPORTED AN IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24925735 ↗
InjuryApr 20, 2026Failure to Osseointegrate
CUSTOMER REPORTED AN IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24925529 ↗
InjuryJun 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22188463 ↗
InjuryJun 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22188459 ↗
InjuryJun 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22188454 ↗
InjuryMay 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22111939 ↗
InjuryDec 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 20830492 ↗
InjuryDec 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 20817694 ↗
InjuryDec 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 20817670 ↗
InjuryNov 22, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THAN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20763913 ↗
InjuryNov 7, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20628072 ↗
InjuryOct 2, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY
Patient problems: Failure of Implant
MAUDE report 20349811 ↗
InjuryOct 2, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. LESS THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20349633 ↗
InjuryOct 1, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20341848 ↗
InjuryOct 1, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. LESS THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20341768 ↗
InjurySep 30, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20331257 ↗
InjurySep 29, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. LESS THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20329843 ↗
InjurySep 15, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. LESS THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20220418 ↗
InjurySep 15, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20220409 ↗
InjurySep 9, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. LESS THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20170351 ↗
InjurySep 8, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. DAY OF SURGERY/0-4 WEEKS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20165364 ↗
InjuryAug 28, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. DAY OF SURGERY/0-4 WEEKS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20088805 ↗
InjuryAug 25, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20060601 ↗
InjuryAug 25, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED, THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20060140 ↗

Device details

UDI-DI	`07290108991963`
Brand	MIS LANCE
Model	EF5-11375
Company	MIS Implants Technologies Ltd.
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	May 17, 2022

Device type (GMDN): Basket 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 single, double, and/or triple contiguous cylinder(s) 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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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