SPI CONTACT INICELL 4.23.214Recalls & 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 SPI CONTACT INICELL dental implant is a tooth implant placed in the jawbone. Its 105 reports, all injury reports, mostly describe the implant failing to fuse with the bone, with some describing movement of the implant, infection and inflammation around it, and pain. There were 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
- 105
- Deaths reported
- 0
- Injuries reported
- 105
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 07640156471090), received between Feb 19, 2018 and Aug 28, 2026 — classified as 105 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (85 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 Osseointegrate85
- Loss of Osseointegration19
- Break1
Patient problems
- Inadequate Osseointegration69
- No Code Available35
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 105 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration.
Patient problems: Inadequate Osseointegration
MAUDE report 50492838 ↗InjuryAug 28, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, implant wasn't completely covered with bone, no thread tap used, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50491628 ↗InjuryJun 8, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, DIABETES MELLITUS, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25425637 ↗InjuryJun 1, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERIODONTAL DISEASE, IMMEDIATE IMPLANTATION, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25354150 ↗InjuryJan 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERI-IMPLANTITIS, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24176414 ↗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 23567755 ↗InjuryNov 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23521051 ↗InjurySep 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22975986 ↗InjurySep 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SWELLING, BLEEDING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22849320 ↗InjuryMar 20, 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, PERIODONTAL DISEASE, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, BONE RESORPTION, PERI-IMPLANTITIS, PAIN, ABSCESS, INFLAMMATION, MOBILITY (2025_0326 AND 0327 ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 21652090 ↗InjuryMar 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, SMOKER, PERIODONTAL DISEASE, DISEASED MUCOUS MEMBRANE, BONE RESORPTION, PERI-IMPLANTITIS, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 21640509 ↗InjuryJan 20, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, DIABETES MELLITUS, BRUXISM.
Patient problems: Inadequate Osseointegration
MAUDE report 21191075 ↗InjuryJan 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PERIODONTAL DISEASE, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 21189181 ↗InjuryNov 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20808598 ↗InjuryNov 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, BONE RESORPTION, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20607804 ↗InjurySep 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 6, 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 20154731 ↗InjurySep 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMMEDIATE IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20145932 ↗InjuryApr 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION.
Patient problems: Inadequate Osseointegration
MAUDE report 19131988 ↗InjuryMar 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, XEROSTOMIA, PERIODONTAL DISEASE, COMPLICATION IN SITE PREPARATION, IMMEDIATE IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 18919947 ↗InjuryMar 1, 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.
Patient problems: Inadequate Osseointegration
MAUDE report 18815561 ↗InjuryFeb 28, 2024Break; Break
IMPLANT FRACTURE, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, COMPROMISED IMMUNE RESISTANCE, BLEEDING, MOBILITY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18795686 ↗InjuryFeb 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION (2024_0589, 2024_0590 AND 2024_0591 ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 18795208 ↗InjuryFeb 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION (2024_0589, 2024_0590 AND 2024_0591 ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 18795206 ↗
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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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