SPI ELEMENT INICELL 4.23.553Recalls & 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 is a Thommen Medical SPI ELEMENT INICELL dental implant, a root-form screw placed into the jawbone. The 36 reports mostly describe the implant failing to fuse with the bone, or losing that bond later, so it becomes loose and mobile; reports also mention pain, swelling, bleeding and infection around the implant. There are no deaths, and 36 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
- 36
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 07640156470024), received between Mar 23, 2018 and Jan 30, 2026 — classified as 36 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (22 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 Osseointegrate22
- Loss of Osseointegration13
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Inadequate Osseointegration26
- No Code Available9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
InjuryJan 30, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24219622 ↗InjuryJan 21, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 24129959 ↗InjurySep 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, IMMEDIATE IMPLANTATION, BONE RESORPTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23073594 ↗InjuryJun 17, 2025Loss 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, PAIN ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 22217506 ↗InjuryJun 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, IMMEDIATE IMPLANTATION, PAIN, SWELLING, BLEEDING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22194400 ↗InjuryFeb 6, 2025Loss 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, DIABETES MELLITUS, XEROSTOMIA, IMMEDIATE IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 21321002 ↗InjuryFeb 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, DRUG OR ALCOHOL ABUSE, XEROSTOMIA, SMOKER, PERI-IMPLANTITIS, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 21320312 ↗InjuryOct 10, 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, DIABETES MELLITUS, SMOKER, PERIODONTAL DISEASE, PERI-IMPLANTITIS, INFECTION, SWELLING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20418951 ↗InjuryOct 9, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20411863 ↗InjuryMar 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SWELLING
Patient problems: Inadequate Osseointegration
MAUDE report 18816082 ↗InjuryDec 22, 2023Loss 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, INFECTION, FISTULA, ABSCESS.
Patient problems: Inadequate Osseointegration
MAUDE report 18382591 ↗InjuryDec 18, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 18344610 ↗InjurySep 22, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, DIABETES MELLITUS, PERI-IMPLANTITIS, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 17797966 ↗InjuryJul 26, 2023Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMMEDIATE IMPLANTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 17395121 ↗InjuryJul 14, 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, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 17323457 ↗InjuryMar 23, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 16597159 ↗InjuryDec 28, 2022Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, COMPLICATION IN SITE PREPARATION.
Patient problems: Inadequate Osseointegration
MAUDE report 16058756 ↗InjuryNov 11, 2022Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERI-IMPLANTITIS.
Patient problems: Inadequate Osseointegration
MAUDE report 15778167 ↗InjuryOct 11, 2022Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, PAIN, MOBILITY. PATIENT PRESENTED WITH SEVERE IMPLANT AND CROWN MOBILITY IT WAS REMOVED WITH FINGERS NO ANESTHESIA NEEDED.
Patient problems: Inadequate Osseointegration
MAUDE report 15578488 ↗InjuryAug 12, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 15215803 ↗InjuryApr 5, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 14011921 ↗InjuryMar 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, COMPROMISED IMMUNE RESISTANCE, XEROSTOMIA, IMMEDIATE IMPLANTATION, INFECTION, INCREASED SENSITIVITY, SWELLING, INFLAMMATION. COMPROMISED IMMUNE SYSTEM CAUSED EXCESSIVE INFECTION AND REJECTION OF IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 13822186 ↗InjuryFeb 25, 2022Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 13597252 ↗InjuryNov 7, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IMPLANT LOSS, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SWELLING, FISTULA. SAME PATIENT AS (B)(6).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12757707 ↗InjuryNov 3, 2021Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 12743373 ↗
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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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