SPI ELEMENT INICELL 4.23.122Recalls & 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 SPI Element Inicell is a dental implant placed into the jawbone. Most of its 981 reports describe the implant failing to fuse with the surrounding bone, and some describe it becoming loose, painful or inflamed. The reports mention no deaths and 981 injuries. 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
- 968
- Deaths reported
- 0
- Injuries reported
- 968
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 968 adverse event reports that list this exact device (DI 07640156471250), received between Jan 22, 2018 and Aug 28, 2026 — classified as 968 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (723 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 Osseointegrate723
- Loss of Osseointegration242
- Loosening of Implant Not Related to Bone-Ingrowth2
- Patient-Device Incompatibility1
Patient problems
- Inadequate Osseointegration766
- No Code Available200
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 25 most recent of 968 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, no thread tap used, inadequate bone quality/quantity, numbness, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50492517 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration, immediate implantation, swelling, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50471336 ↗InjuryAug 5, 2026Failure to Osseointegrate
Primary stability not achieved, thread tap used.
Patient problems: Inadequate Osseointegration
MAUDE report 50139411 ↗InjuryJul 15, 2026Loss of Osseointegration
InjuryJul 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION. SMOKER. PERIODONTAL DISEASE. PERI-IMPLANTITIS. PAIN. INFLAMMATION. MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25823049 ↗InjuryJul 15, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION. PRIMARY STABILITY WAS ACHIEVED. IMPLANT WAS COMPLETELY COVERED WITH BONE. NO THREAD TAP USED. MOBILITY. (B)(6) ARE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 25822998 ↗InjuryJul 14, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25812931 ↗InjuryJul 14, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, DIABETES MELLITUS, SMOKER, PERIODONTAL DISEASE, PERI-IMPLANTITIS, INFECTION, MOBILITY (B)(4) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25812904 ↗InjuryJul 14, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 25812406 ↗InjuryJul 14, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25811509 ↗InjuryJul 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25810247 ↗InjuryJul 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SWELLING, ABSCESS (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 25795148 ↗InjuryJul 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SWELLING, ABSCESS ((B)(6) AND (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 25795142 ↗InjuryJul 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER, PAIN, SWELLING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25794025 ↗InjuryJul 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED.
Patient problems: Inadequate Osseointegration
MAUDE report 25792808 ↗InjuryJul 10, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY
Patient problems: Inadequate Osseointegration
MAUDE report 25775023 ↗InjuryJul 10, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 25774903 ↗InjuryJul 9, 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 25761493 ↗InjuryJul 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERI-IMPLANTITIS, PAIN, INCREASED SENSITIVITY, SWELLING, BLEEDING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25744047 ↗InjuryJul 7, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25732685 ↗InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25730364 ↗InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, OVERHEATING OF BONE (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25728914 ↗InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, OVERHEATING OF BONE (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25728912 ↗InjuryJul 6, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 25713729 ↗InjuryJul 6, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25713694 ↗
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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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