SPI CONTACT INICELL 4.23.615Recalls & 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 Contact Inicell dental implant; reports mostly describe implants failing to integrate with bone or losing integration, sometimes involving resorption, infection or pain, with a few parts breaking. It has 91 adverse event reports, no deaths, 91 injuries and no recalls.
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
- 91
- Deaths reported
- 0
- Injuries reported
- 91
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 07640156470710), received between Jan 19, 2018 and Jun 12, 2026 — classified as 91 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (76 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 Osseointegrate76
- Loss of Osseointegration13
- Break2
Patient problems
- Inadequate Osseointegration68
- No Code Available22
Recent adverse event reports
The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMMEDIATE IMPLANTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25482367 ↗InjuryJun 2, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, NUMBNESS.
Patient problems: Inadequate Osseointegration
MAUDE report 25357814 ↗InjuryApr 13, 2026Failure to Osseointegrate
InjuryJan 8, 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 24001715 ↗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.
Patient problems: Inadequate Osseointegration
MAUDE report 23987512 ↗InjuryJan 6, 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 23971756 ↗InjuryJan 6, 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 ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 23971507 ↗InjuryJan 5, 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, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23958297 ↗InjuryAug 11, 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, FISTULA.
Patient problems: Inadequate Osseointegration
MAUDE report 22769358 ↗InjuryAug 5, 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, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22715391 ↗InjuryJul 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22541453 ↗InjuryJul 18, 2025Break; Break
IMPLANT FRACTURE, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22540829 ↗InjuryMay 27, 2025Break; Break
IMPLANT FRACTURE, SMOKER, PERIODONTAL DISEASE, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22086821 ↗InjuryMar 21, 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, PAIN, SWELLING.
Patient problems: Inadequate Osseointegration
MAUDE report 21663152 ↗InjuryMar 5, 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, BISPHOSPHONATE TREATMENT, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 21523463 ↗InjuryFeb 7, 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, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 21332527 ↗InjuryFeb 7, 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, PAIN ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 21332223 ↗InjuryFeb 7, 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, PAIN ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 21332210 ↗InjuryFeb 7, 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, DIABETES MELLITUS, INADEQUATE BONE QUALITY/QUANTITY, PERI-IMPLANTITIS, ABSCESS, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 21330923 ↗InjuryJan 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, DIABETES MELLITUS, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 21189600 ↗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 20808774 ↗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 20661672 ↗InjuryOct 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 20396326 ↗InjuryOct 8, 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.
Patient problems: Inadequate Osseointegration
MAUDE report 20395948 ↗InjuryOct 8, 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
Patient problems: Inadequate Osseointegration
MAUDE report 20395930 ↗
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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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