SPI ELEMENT INICELL 4.23.154Recalls & reported problems

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

Adverse event reports: 16
Deaths reported: 0
Injuries reported: 16
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07640156470741), received between Mar 29, 2019 and May 29, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (12 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

Failure to Osseointegrate12
Loss of Osseointegration4

Patient problems

Inadequate Osseointegration11
No Code Available5

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

InjuryMay 29, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, DIABETES MELLITUS, BRUXISM, BONE RESORPTION, PERI-IMPLANTITIS, PAIN, SWELLING, BLEEDING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25330419 ↗
InjuryAug 13, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, TRAUMA / ACCIDENT, BRUXISM, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22792021 ↗
InjuryJul 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, ILLNESS REQUIRING STEROIDS, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, PAIN, SWELLING.
Patient problems: Inadequate Osseointegration
MAUDE report 22541379 ↗
InjuryFeb 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED (2025_0119 AND 0120 ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 21457282 ↗
InjuryOct 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, IMMEDIATE IMPLANTATION, INADEQUATE BONE QUALITY/QUANTITY, PRECEDING/SIMULTANEOUS BONE AUGMENTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20493211 ↗
InjurySep 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, INCREASED SENSITIVITY, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20179110 ↗
InjuryJan 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFECTION.
Patient problems: Inadequate Osseointegration
MAUDE report 18543151 ↗
InjuryJan 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED.
Patient problems: Inadequate Osseointegration
MAUDE report 18501005 ↗
InjuryMar 11, 2022Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 13729773 ↗
InjuryJan 4, 2022Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMMEDIATE IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 13152163 ↗
InjuryJun 22, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT REMOVAL DUE TO PATIENT CONDITION, PRIMARY STABILITY WAS ACHIEVED, DIABETES MELLITUS, IMMEDIATE IMPLANTATION, PAIN, NUMBNESS, SWELLING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 12041022 ↗
InjuryOct 12, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFLAMMATION, MOBILITY. CONNECTIVE TISSUE HEALING.
Patient problems: No Code Available
MAUDE report 10660583 ↗
InjuryMar 13, 2020Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED.
Patient problems: No Code Available
MAUDE report 9828242 ↗
InjurySep 6, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE.
Patient problems: No Code Available
MAUDE report 8968898 ↗
InjuryMay 6, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS. IMPLANT DID NOT FIT AND WAS THEREFORE NOT PLACED. ANOTHER ONE WITH PF 6.0 AND 8MM LENGTH HAS BEEN PLACED SUCCESSFULLY.
Patient problems: No Code Available
MAUDE report 8581906 ↗
InjuryMar 29, 2019Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, THREAD TAP USED, PRIMARY STABILITY WAS ACHIEVED, IMPLANT ACHIEVED OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED BY BONE, MOBILITY PATIENT CAME TO OFFICE (B)(6) 2019 REPORTING LOOSE IMPLANT - IT WAS SO LOOSE, INSTRUMENTATION NOT NEEDED TO REMOVE.
Patient problems: No Code Available
MAUDE report 8463220 ↗

Device details

UDI-DI	`07640156470741`
Brand	SPI ELEMENT INICELL
Model	4.23.154
Company	Thommen Medical AG
Product code	DZE · Implant, Endosseous, Root-Form
Class	Class 2
FDA submission	K090154
Implant	Yes
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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