SPI ELEMENT INICELL 4.23.144Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
All models of SPI ELEMENT INICELL (67)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Thommen SPI Element Inicell is a dental implant. It has 197 adverse event reports, with no deaths and 197 injuries. Most describe the implant failing to bond with the bone or not feeling stable at placement. No recalls name this device.
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
- 197
- Deaths reported
- 0
- Injuries reported
- 197
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 197 adverse event reports that list this exact device (DI 07640156471120), received between Feb 15, 2018 and Sep 15, 2026 — classified as 197 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (162 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
Most reported problems
Device problems
- Failure to Osseointegrate162
- Loss of Osseointegration35
Patient problems
- Inadequate Osseointegration134
- No Code Available63
Recent adverse event reports
The 25 most recent of 197 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved.
Patient problems: Inadequate Osseointegration
MAUDE report 50770679 ↗InjuryAug 27, 2026Failure to Osseointegrate
Primary stability not achieved, implant wasn't completely covered with bone, no thread tap used - another size of implant was chosen.
Patient problems: Inadequate Osseointegration
MAUDE report 50469811 ↗InjuryJul 14, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERI-IMPLANTITIS
Patient problems: Inadequate Osseointegration
MAUDE report 25812465 ↗InjuryApr 28, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMMEDIATE IMPLANTATION, MOBILITY (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25016286 ↗InjuryApr 27, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24996673 ↗InjuryMar 17, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, COMPLICATION IN SITE PREPARATION, INADEQUATE BONE QUALITY/QUANTITY - ANOTHER SIZE OF IMPLANT WAS CHOSEN.
Patient problems: Inadequate Osseointegration
MAUDE report 24617740 ↗InjuryMar 4, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, BLEEDING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24510916 ↗InjuryFeb 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, PERI-IMPLANTITIS, INFECTION, INCREASED SENSITIVITY, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24411882 ↗InjuryFeb 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERI-IMPLANTITIS, PAIN, ABSCESS.
Patient problems: Inadequate Osseointegration
MAUDE report 24411798 ↗InjuryFeb 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24411595 ↗InjuryFeb 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24388752 ↗InjuryJan 5, 2026Failure to Osseointegrate
InjuryNov 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, SMOKER, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, INFECTION, PAIN, INCREASED SENSITIVITY, BLEEDING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23628872 ↗InjuryNov 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, SMOKER, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23614245 ↗InjuryAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 22892194 ↗InjuryAug 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 22882754 ↗InjuryAug 25, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, DIABETES MELLITUS ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 22780564 ↗InjuryAug 6, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22724612 ↗InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22585642 ↗InjuryJul 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22552032 ↗InjuryJul 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22518294 ↗InjuryJun 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, INADEQUATE BONE QUALITY/QUANTITY, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22158756 ↗InjuryMay 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, INFECTION, PAIN ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 22058951 ↗InjuryMay 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER.
Patient problems: Inadequate Osseointegration
MAUDE report 22010375 ↗
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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 13, 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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