SPI ELEMENT INICELL 4.23.516Recalls & 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
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07640156470260), received between Feb 24, 2018 and Apr 10, 2026 — classified as 22 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (17 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 Osseointegrate17
- Loss of Osseointegration5
Patient problems
- Inadequate Osseointegration14
- No Code Available8
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERIODONTAL DISEASE, TRAUMA / ACCIDENT, PERI-IMPLANTITIS, INFECTION.
Patient problems: Inadequate Osseointegration
MAUDE report 24843862 ↗InjuryJun 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, XEROSTOMIA, PERIODONTAL DISEASE, DISEASED MUCOUS MEMBRANE, PERI-IMPLANTITIS, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22283845 ↗InjuryOct 1, 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, PERIODONTAL DISEASE, IMMEDIATE IMPLANTATION, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, INFECTION, PAIN, INCREASED SENSITIVITY, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 20342315 ↗InjurySep 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, INFECTION, MOBILITY (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 20331902 ↗InjurySep 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, INFECTION, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 20331896 ↗InjuryJul 26, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERI-IMPLANTITIS, INFECTION, MOBILITY. IMPLANTS #12, 11, 21, 22 WERE POORLY TREATED BY THE REFERRER, RESULTING IN INADEQUATE HYGIENE AND LOSS.
Patient problems: Inadequate Osseointegration
MAUDE report 19835942 ↗InjuryJan 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, COMPLICATION IN SITE PREPARATION (CORTICAL BONE VERY HARD), UNDERSIZED IMPLANT BED.
Patient problems: Inadequate Osseointegration
MAUDE report 18586888 ↗InjuryDec 22, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, IMMEDIATE IMPLANTATION, BLEEDING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 18382777 ↗InjuryOct 17, 2023Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, BLOOD COAGULATION DISORDER, COMPLICATION IN SITE PREPARATION.
Patient problems: Inadequate Osseointegration
MAUDE report 17948347 ↗InjurySep 1, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 17668982 ↗InjuryAug 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, BLEEDING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 17451566 ↗InjuryJan 27, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 30, 2021Failure 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, IMMEDIATE IMPLANTATION, PERI-IMPLANTITIS, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 12725233 ↗InjuryJan 22, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, PERIODONTAL DISEASE, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 11214727 ↗InjuryAug 10, 2020Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED. SAME PATIENT AS (B)(6).
Patient problems: No Code Available
MAUDE report 10383516 ↗InjuryFeb 1, 2019Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT ACHIEVED OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED BY BONE, PERI-IMPLANTITIS, INFECTION, PAIN, MOBILITY.PATIENT CAME FROM A REFERRER WHO HAD NOT PERFORMED THE NECESSARY CONTROL AND HYGIENE MEASURES.
Patient problems: No Code Available
MAUDE report 8295891 ↗InjurySep 22, 2018Loss of Osseointegration; Loss of Osseointegration
IMPLANT LOST OSSEOINTEGRATION AFTER 5 WEEKS. NO MORE INFORMATION RECEIVED FROM DENTIST.
Patient problems: No Code Available
MAUDE report 7900436 ↗InjuryApr 21, 2018Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY ACHIEVED, NO OSSEOINTEGRATION.
Patient problems: No Code Available
MAUDE report 7449436 ↗InjuryApr 21, 2018Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY ACHIEVED, NO OSSEOINTEGRATION.
Patient problems: No Code Available
MAUDE report 7449435 ↗InjuryApr 19, 2018Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY ACHIEVED, NO OSSEOINTEGRATION, PAIN, FISTULA, INFECTION.
Patient problems: No Code Available
MAUDE report 7443413 ↗InjuryMar 17, 2018Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY ACHIEVED, NO OSSEOINTEGRATION. IMMEDIATE IMPLANTATION, PAIN, INSTABILITY.
Patient problems: No Code Available
MAUDE report 7347560 ↗InjuryFeb 24, 2018Failure to Osseointegrate; Failure to Osseointegrate
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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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