SPI ELEMENT INICELL 4.23.133Recalls & 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 dental implant appears in 891 adverse event reports, with 891 injuries and no deaths. Most describe the implant failing to fuse with the surrounding bone, and many note poor initial stability at placement. Some mention peri-implantitis, infection and bone loss around the implant. 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
- 894
- Deaths reported
- 0
- Injuries reported
- 894
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 894 adverse event reports that list this exact device (DI 07640156471199), received between Jan 19, 2018 and Sep 29, 2026 — classified as 894 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (733 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 Osseointegrate733
- Loss of Osseointegration149
- Break6
- Loosening of Implant Not Related to Bone-Ingrowth4
- Appropriate Device Problem Term/Code Not Available1
- Device Handling Problem1
Patient problems
- Inadequate Osseointegration658
- No Code Available228
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Implant Pain1
Recent adverse event reports
The 25 most recent of 894 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Osseointegrate
Primary stability not achieved, implant wasn't completely covered with bone, no thread tap used, inadequate bone quality/quantity, preceding/simultaneous bone augmentation, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50930938 ↗InjurySep 28, 2026Failure to Osseointegrate
Primary stability not achieved, implant was completely covered with bone, no thread tap used.
Patient problems: Inadequate Osseointegration
MAUDE report 50912515 ↗InjurySep 28, 2026Failure to Osseointegrate
Primary stability not achieved, periodontal disease, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50912495 ↗InjurySep 28, 2026Failure to Osseointegrate
Primary stability not achieved, implant wasn't completely covered with bone, no thread tap used.
Patient problems: Inadequate Osseointegration
MAUDE report 50912401 ↗InjurySep 28, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, infection, swelling, inflammation, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50911072 ↗InjuryAug 27, 2026Failure to Osseointegrate
Primary stability not achieved, implant was completely covered with bone, no thread tap used.
Patient problems: Inadequate Osseointegration
MAUDE report 50469478 ↗InjuryAug 26, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, implant was completely covered with bone, no thread tap used, inadequate bone quality/quantity.
Patient problems: Inadequate Osseointegration
MAUDE report 50450709 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseoinegration, peri-implantitis.
Patient problems: Inadequate Osseointegration
MAUDE report 50208247 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, smoker, bleeding, inflammation.
Patient problems: Inadequate Osseointegration
MAUDE report 50207308 ↗InjuryAug 10, 2026Failure to Osseointegrate
Primary stability not achieved, smoker.
Patient problems: Inadequate Osseointegration
MAUDE report 50191588 ↗InjuryAug 5, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, overheating of bone, inadequate bone quality/quantity, bone resorption, peri-implantitis, infection, swelling, abscess, inflammation.
Patient problems: Inadequate Osseointegration
MAUDE report 50140577 ↗InjuryJul 14, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25811593 ↗InjuryJul 14, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25810025 ↗InjuryJul 13, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY - ANOTHER SIZE OF IMPLANT WAS CHOSEN
Patient problems: Inadequate Osseointegration
MAUDE report 25796767 ↗InjuryJul 10, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED
Patient problems: Inadequate Osseointegration
MAUDE report 25774873 ↗InjuryJul 10, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PAIN
Patient problems: Inadequate Osseointegration
MAUDE report 25774844 ↗InjuryJul 8, 2026Failure to Osseointegrate
InjuryJul 6, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERI-IMPLANTITIS, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25714373 ↗InjuryJun 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25590273 ↗InjuryJun 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25577660 ↗InjuryJun 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERI-IMPLANTITIS, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25577280 ↗InjuryJun 15, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, XEROSTOMIA, SMOKER, PERIODONTAL DISEASE, UNDERSIZED IMPLANT BED, INFECTION, PAIN, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25501016 ↗InjuryJun 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25500833 ↗InjuryJun 10, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PSYCHOLOGICAL DISORDER, DRUG OR ALCOHOL ABUSE, PERIODONTAL DISEASE, COMPLICATION IN SITE PREPARATION, SINUS PERFORATION, PRECEDING/SIMULTANEOUS BONE AUGMENTATION ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25455540 ↗InjuryJun 10, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PSYCHOLOGICAL DISORDER, DRUG OR ALCOHOL ABUSE, PERIODONTAL DISEASE, COMPLICATION IN SITE PREPARATION, SINUS PERFORATION, PRECEDING/SIMULTANEOUS BONE AUGMENTATION (B)(6) AND (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 25455513 ↗
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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 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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