ANKYLOS® 31056021 (UDI 07392532222139)Recalls & reported problems

Dentsply Implants Manufacturing GmbH · Retaining Screw, occlusal hexagon M1.6 · Class 2 · Implant

All models of ANKYLOS (112)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 17
Deaths reported: 0
Injuries reported: 10
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07392532222139), received between Jan 9, 2026 and Jun 2, 2026 — classified as 10 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (17 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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Fracture17

Patient problems

No Clinical Signs, Symptoms or Conditions17
Osteolysis2
Inflammation1
Unspecified Infection1

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

InjuryJun 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL ABUTMENT SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25358824 ↗
InjuryJun 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL ABUTMENT SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25358798 ↗
InjuryJun 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL ABUTMENT SCREW WHERE THE SCREW IS STUCK IN THE ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25358756 ↗
InjuryJun 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL ABUTMENT SCREW WHERE THE SCREW IS STUCK IN THE ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25358716 ↗
InjuryJun 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL ABUTMENT SCREW WHERE THE SCREW IS STUCK IN THE ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25358676 ↗
InjuryJun 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL ABUTMENT SCREW WHERE THE SCREW IS STUCK IN THE ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25358651 ↗
InjuryJun 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL ABUTMENT SCREW WHERE THE SCREW IS STUCK IN THE ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25358621 ↗
InjuryJan 27, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Osteolysis
MAUDE report 24193620 ↗
InjuryJan 27, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24193547 ↗
InjuryJan 27, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: Inflammation; No Clinical Signs, Symptoms or Conditions; Osteolysis; Unspecified Infection
MAUDE report 24193478 ↗
MalfunctionJan 9, 2026Fracture
IT WAS REPORTED THE CUSTOMER EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24016969 ↗
MalfunctionJan 9, 2026Fracture
IT WAS REPORTED THE CUSTOMER EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24016968 ↗
MalfunctionJan 9, 2026Fracture
IT WAS REPORTED THE CUSTOMER EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24016967 ↗
MalfunctionJan 9, 2026Fracture
IT WAS REPORTED THE CUSTOMER EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24016966 ↗
MalfunctionJan 9, 2026Fracture
IT WAS REPORTED THE CUSTOMER EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24016965 ↗
MalfunctionJan 9, 2026Fracture
IT WAS REPORTED THE CUSTOMER EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24016964 ↗
MalfunctionJan 9, 2026Fracture
IT WAS REPORTED THE CUSTOMER EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24016962 ↗

Device details

UDI-DI	`07392532222139`
Brand	ANKYLOS®
Model	31056021
Company	Dentsply Implants Manufacturing GmbH
Product code	DZE · IMPLANT, ENDOSSEOUS, ROOT-FORM
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 7, 2024

Device type (GMDN): Dental implant suprastructure, permanent, preformed

A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
43,616 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
40,404 reports
Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
27,400 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
25,621 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
25,298 reports
Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
23,448 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
22,320 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
22,267 reports

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 16, 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