SPI ELEMENT INICELL 4.23.142Recalls & 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 is anchored in the jawbone. Most of the 590 reports describe the implant not fusing with the bone, and some mention inflammation around it. The reports include 590 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
- 583
- Deaths reported
- 0
- Injuries reported
- 583
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 583 adverse event reports that list this exact device (DI 07640156471144), received between Jan 20, 2018 and Aug 27, 2026 — classified as 583 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (453 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 Osseointegrate453
- Loss of Osseointegration128
- Loosening of Implant Not Related to Bone-Ingrowth2
Patient problems
- Inadequate Osseointegration434
- No Code Available147
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 25 most recent of 583 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Failure to Osseointegrate
Primary stability not achieved ((b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50469871 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, drug or alcohol abuse, infection, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50468838 ↗InjuryAug 17, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, no thread tap used, preceding/simultaneous bone augmentation, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50270725 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration, inadequate bone quality/quantity, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50208258 ↗InjuryAug 5, 2026Failure to Osseointegrate
InjuryAug 5, 2026Loss of Osseointegration
Loss of osseointegration, peri-implantitis.
Patient problems: Inadequate Osseointegration
MAUDE report 50141267 ↗InjuryAug 5, 2026Failure to Osseointegrate
Primary stability not achieved, thread tap used.
Patient problems: Inadequate Osseointegration
MAUDE report 50139367 ↗InjuryAug 4, 2026Loss of Osseointegration
Loss of osseointegration, inflammation, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50127155 ↗InjuryJul 15, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25824527 ↗InjuryJul 14, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY (2026_1604 AND 1605 ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25812430 ↗InjuryJul 9, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS 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 25761615 ↗InjuryJul 8, 2026Loss of Osseointegration
InjuryJun 23, 2026Loss of Osseointegration
InjuryJun 23, 2026Loss of Osseointegration
InjuryJun 10, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25455710 ↗InjuryJun 10, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PSYCHOLOGICAL DISORDER, SMOKER, PERIODONTAL DISEASE, TRAUMA / ACCIDENT, PERI-IMPLANTITIS, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25455473 ↗InjuryJun 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SWELLING, FISTULA, BLEEDING, INFLAMMATION, MOBILITY ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25370961 ↗InjuryMay 26, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25275764 ↗InjuryMay 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, SWELLING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25214783 ↗InjuryMay 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, CHEMOTHERAPY AROUND TIME OF IMPLANT PLACEMENT, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25214779 ↗InjuryApr 29, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, INFECTION, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25026747 ↗InjuryApr 29, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25025590 ↗InjuryApr 28, 2026Failure to Osseointegrate
InjuryApr 28, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, THREAD TAP USED, PAIN, INCREASED SENSITIVITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25016760 ↗InjuryApr 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, SMOKER, BONE RESORPTION, INFECTION, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 24952019 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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