SPI ELEMENT INICELL 4.23.145Recalls & 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 is a Thommen Medical SPI ELEMENT Inicell dental implant, a root-form screw placed in the jawbone. Most of the 59 reports describe the implant failing to fuse with the bone or losing that fusion later, sometimes with mobility, infection, or pain; all 59 involve injuries and no deaths are reported. There are no recalls naming this device, and reporting has held steady at 3 reports in each of the last two 12-month periods.
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
- 59
- Deaths reported
- 0
- Injuries reported
- 59
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 07640156471113), received between Jan 19, 2018 and Apr 28, 2026 — classified as 59 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (44 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 Osseointegrate44
- Loss of Osseointegration15
Patient problems
- Inadequate Osseointegration36
- No Code Available23
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
InjuryApr 28, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMMEDIATE IMPLANTATION, MOBILITY (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25016300 ↗InjuryFeb 19, 2026Failure to Osseointegrate
InjuryJan 21, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, IMMEDIATE IMPLANTATION, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24130389 ↗InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMMEDIATE IMPLANTATION, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 23003090 ↗InjuryApr 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 21760683 ↗InjuryFeb 25, 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, PRECEDING/SIMULTANEOUS BONE AUGMENTATION (2025_0114 AND 0115 ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 21457097 ↗InjuryOct 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PERIODONTAL DISEASE, INFECTION ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 20341988 ↗InjuryOct 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 20341641 ↗InjurySep 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20299971 ↗InjurySep 6, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, DIABETES MELLITUS, PERI-IMPLANTITIS, SWELLING, FISTULA, BLEEDING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20154885 ↗InjuryAug 16, 2024Failure to Osseointegrate; Failure 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 19998599 ↗InjuryAug 16, 2024Loss of Osseointegration; Loss 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. (B)(6) ARE THE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 19998174 ↗InjuryAug 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFLAMMATION. (B)(6) ARE THE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 19998041 ↗InjuryJul 15, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19738483 ↗InjuryJun 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, DIABETES MELLITUS.
Patient problems: Inadequate Osseointegration
MAUDE report 19379585 ↗InjuryMay 2, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 19227654 ↗InjuryApr 5, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERI-IMPLANTITIS. IMPLANT WAS PLACED FOR SOME TIME BY ANOTHER DENTIST - THE EXACT DATE IS NOT KNOWN.
Patient problems: Inadequate Osseointegration
MAUDE report 19048655 ↗InjuryFeb 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, DIABETES MELLITUS, PERIODONTAL DISEASE, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, BLEEDING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 18629410 ↗InjuryJan 28, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, DRUG OR ALCOHOL ABUSE.
Patient problems: Inadequate Osseointegration
MAUDE report 18592890 ↗InjuryJun 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMMEDIATE IMPLANTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 17143093 ↗InjuryMay 29, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, SMOKER, PERI-IMPLANTITIS, PAIN, SWELLING, ABSCESS.
Patient problems: Inadequate Osseointegration
MAUDE report 17016496 ↗InjuryMar 26, 2023Failure 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, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 16616770 ↗InjuryNov 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, IMMEDIATE IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 14954873 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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