MIS LANCE EF5-13420Recalls & reported problems

MIS Implants Technologies Ltd. · Lance external hex. implant dia. 4.20 L 13mm · Class 2 · Implant

Adverse event reports: 19
Deaths reported: 0
Injuries reported: 19
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07290108991901), received between Aug 13, 2024 and Feb 19, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (15 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 Problem15
Failure to Osseointegrate4

Patient problems

Failure of Implant19

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

InjuryFeb 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21410464 ↗
InjuryFeb 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21410407 ↗
InjuryFeb 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21410198 ↗
InjuryFeb 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21393233 ↗
InjuryNov 13, 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 20675004 ↗
InjuryNov 11, 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 20650499 ↗
InjuryNov 10, 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 20648742 ↗
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 20341805 ↗
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 20331493 ↗
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 20331434 ↗
InjurySep 18, 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 20243721 ↗
InjurySep 18, 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 20243687 ↗
InjurySep 18, 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 20243677 ↗
InjurySep 10, 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 20178185 ↗
InjurySep 9, 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 20166680 ↗
InjurySep 4, 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 20133658 ↗
InjuryAug 25, 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 20060760 ↗
InjuryAug 13, 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 19972161 ↗
InjuryAug 13, 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 19972125 ↗

Device details

UDI-DI	`07290108991901`
Brand	MIS LANCE
Model	EF5-13420
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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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.