SPI ELEMENT INICELL 4.23.123Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
All models of SPI ELEMENT INICELL (67)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Thommen SPI Element INICELL dental implant is placed in the jawbone. Most of its 1,171 reports describe implants that fail to fuse with the bone or lose that fusion, and some mention swelling, bleeding, implant movement and infection. The reports include 1,171 injuries and no deaths. 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
- 1,169
- Deaths reported
- 0
- Injuries reported
- 1,169
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,169 adverse event reports that list this exact device (DI 07640156471243), received between Jan 7, 2018 and Sep 28, 2026 — classified as 1,169 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (924 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate924
- Loss of Osseointegration239
- Loosening of Implant Not Related to Bone-Ingrowth6
Patient problems
- Inadequate Osseointegration823
- No Code Available342
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Implant Pain1
Recent adverse event reports
The 25 most recent of 1,169 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, smoker, bone resorption, bleeding ((b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50913211 ↗InjurySep 28, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, smoker, peri-implantitis, pain, mobility ((b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50913174 ↗InjurySep 28, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, bone resorption, peri-implantitis, infection, inflammation, mobility ((b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50911738 ↗InjurySep 28, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, bone resorption, peri-implantitis, infection, inflammation, mobility ((b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50911729 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, pain, swelling, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50753882 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, pain, increased sensitivity, inflammation, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50753836 ↗InjurySep 14, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant wasn't completely covered with bone, no thread tap used, preceding/simultaneous bone augmentation, infection, swelling, abscess, bleeding, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50750475 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration, primary stability was achieved, implant was completely covered with bone, swelling, bleeding, mobility ((b)(6) and (b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50471457 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration, infection, swelling, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50471376 ↗InjuryAug 27, 2026Failure to Osseointegrate
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 50469470 ↗InjuryAug 17, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration.
Patient problems: Inadequate Osseointegration
MAUDE report 50270803 ↗InjuryAug 11, 2026Loss of Osseointegration
InjuryAug 10, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration.
Patient problems: Inadequate Osseointegration
MAUDE report 50191541 ↗InjuryAug 10, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50191522 ↗InjuryJul 15, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERI-IMPLANTITIS, ABSCESS.
Patient problems: Inadequate Osseointegration
MAUDE report 25825199 ↗InjuryJul 15, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, PERIODONTAL DISEASE, PERI-IMPLANTITIS, INFLAMMATION, AND MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25825115 ↗InjuryJul 15, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 25825031 ↗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, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25809938 ↗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, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25809925 ↗InjuryJul 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25795059 ↗InjuryJul 9, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFECTION, PAIN, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 25761713 ↗InjuryJul 8, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25744124 ↗InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, BRUXISM, PAIN, SWELLING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25733247 ↗InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25730307 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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