SPI CONTACT INICELL 4.23.625Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
All models of SPI CONTACT INICELL (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Thommen Medical SPI Inicell dental implant is an endosseous root-form implant. Reports mostly describe problems with osseointegration, meaning the implant failing to bond with bone or losing that bond, sometimes with infection, pain, swelling or bleeding. There are 89 reports naming its identifier: 89 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
- 89
- Deaths reported
- 0
- Injuries reported
- 89
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 07640156470635), received between Jun 30, 2018 and Jun 2, 2026 — classified as 89 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (69 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 Osseointegrate69
- Loss of Osseointegration20
Patient problems
- Inadequate Osseointegration64
- No Code Available25
Recent adverse event reports
The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SWELLING.
Patient problems: Inadequate Osseointegration
MAUDE report 25359205 ↗InjuryMay 18, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, IMMEDIATE IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25197394 ↗InjuryJan 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 24160594 ↗InjuryJan 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, ABSCESS, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 24158737 ↗InjuryJan 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, ABSCESS, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 24052173 ↗InjuryJan 7, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, ABSCESS, MOBILITY (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 23987683 ↗InjuryNov 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, PERI-IMPLANTITIS, INFECTION, NUMBNESS.
Patient problems: Inadequate Osseointegration
MAUDE report 23567730 ↗InjurySep 10, 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, PSYCHOLOGICAL DISORDER, SMOKER, PERIODONTAL DISEASE, IMMEDIATE IMPLANTATION, PERI-IMPLANTITIS, PAIN, SWELLING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23014875 ↗InjuryMay 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22095254 ↗InjuryMar 27, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERIODONTAL DISEASE.
Patient problems: Inadequate Osseointegration
MAUDE report 21706796 ↗InjuryJan 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, DIABETES MELLITUS, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 21250107 ↗InjuryJan 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED
Patient problems: Inadequate Osseointegration
MAUDE report 21136467 ↗InjurySep 18, 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, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20244256 ↗InjurySep 6, 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. (B)(6) ARE THE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 20154812 ↗InjuryJul 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, IMMEDIATE IMPLANTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19654692 ↗InjuryJul 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, IMMEDIATE IMPLANTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19653588 ↗InjuryJul 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 19653571 ↗InjuryJul 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PAIN (2024_2011 AND 2024_2012 ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 19653302 ↗InjuryJul 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 19653281 ↗InjuryJun 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION, IMMEDIATE IMPLANTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19592614 ↗InjuryMay 17, 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, PSYCHOLOGICAL DISORDER, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, INFECTION, FISTULA, ABSCESS, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 19340088 ↗InjuryApr 12, 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, PAIN. (B)(6) IS THE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 19094657 ↗InjuryApr 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED. ANOTHER IMPLANT HAS BEEN PLACED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 19049178 ↗InjuryMar 18, 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, IMMEDIATE IMPLANTATION, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 18919887 ↗InjuryMar 15, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, PAIN, SWELLING, ABSCESS, BLEEDING, MOBILITY. PATIENT JUST FINISHED ORTHO TREATMENT. THE CROWN WAS SCREW RETAINED, NO CEMENT WAS EVER USED.
Patient problems: Inadequate Osseointegration
MAUDE report 18912296 ↗
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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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