SPI CONTACT INICELL 4.23.233Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
All models of SPI CONTACT INICELL (37)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Thommen Inicell dental implant has 131 reports, all injury reports. Most describe the implant failing to bond with the jawbone, with some reports noting patient pain and infection. The reports mention no deaths, and 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
- 131
- Deaths reported
- 0
- Injuries reported
- 131
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 07640156471021), received between Feb 23, 2018 and May 19, 2026 — classified as 131 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (96 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 Osseointegrate96
- Loss of Osseointegration35
Patient problems
- Inadequate Osseointegration79
- No Code Available52
Recent adverse event reports
The 25 most recent of 131 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25214916 ↗InjuryFeb 3, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 24244835 ↗InjuryFeb 3, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24244793 ↗InjuryJan 9, 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 24017960 ↗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 23987532 ↗InjurySep 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, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23074274 ↗InjuryFeb 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 21310643 ↗InjuryJan 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20661638 ↗InjuryOct 23, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, INFECTION, MOBILITY (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 20512616 ↗InjurySep 30, 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, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20331512 ↗InjurySep 24, 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, PERI-IMPLANTITIS, INCREASED SENSITIVITY, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 20289277 ↗InjurySep 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED.
Patient problems: Inadequate Osseointegration
MAUDE report 20245564 ↗InjurySep 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, BRUXISM, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20223724 ↗InjurySep 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 20187984 ↗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.
Patient problems: Inadequate Osseointegration
MAUDE report 20154779 ↗InjuryAug 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 20084646 ↗InjuryAug 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 20084540 ↗InjuryJul 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PERI-IMPLANTITIS, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19654545 ↗InjuryJul 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NUMBNESS (2024_2023 AND 2024_2024 ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 19653563 ↗InjuryJul 2, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, MOBILITY (2024_2015 AND 2024_2016 ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 19653325 ↗InjuryJul 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 19653026 ↗InjuryJul 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 19644529 ↗InjuryJul 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PERI-IMPLANTITIS.
Patient problems: Inadequate Osseointegration
MAUDE report 19643471 ↗InjuryJul 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER, PERI-IMPLANTITIS.
Patient problems: Inadequate Osseointegration
MAUDE report 19643452 ↗
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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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