SPI CONTACT INICELL 4.23.624Recalls & 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 dental implant is a screw-shaped post placed in the jawbone to hold a replacement tooth. Most of the 289 reports describe the implant failing to bond with the bone or losing that bond. Reports rose from 29 in the prior 12 months to 40 in the last 12 months. The reports include no deaths and 289 injuries. 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
- 289
- Deaths reported
- 0
- Injuries reported
- 289
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 289 adverse event reports that list this exact device (DI 07640156470659), received between Feb 15, 2018 and Jun 2, 2026 — classified as 289 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (235 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 Osseointegrate235
- Loss of Osseointegration53
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Inadequate Osseointegration212
- No Code Available77
Recent adverse event reports
The 25 most recent of 289 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SWELLING.
Patient problems: Inadequate Osseointegration
MAUDE report 25359183 ↗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 25357896 ↗InjuryMay 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, DIABETES MELLITUS, BIOMECHANICAL OVERLOAD, BONE RESORPTION, MOBILITY - IMMEDIATE LOADING.
Patient problems: Inadequate Osseointegration
MAUDE report 25214923 ↗InjuryApr 29, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 25030282 ↗InjuryApr 29, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 25025449 ↗InjuryApr 8, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, INCREASED SENSITIVITY, INFLAMMATION (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24812994 ↗InjuryMar 5, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24516913 ↗InjuryJan 27, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 24188402 ↗InjuryJan 27, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERI-IMPLANTITIS.
Patient problems: Inadequate Osseointegration
MAUDE report 24187611 ↗InjuryJan 23, 2026Failure 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 24160408 ↗InjuryJan 23, 2026Failure 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 24160272 ↗InjuryJan 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, PAIN ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24159754 ↗InjuryJan 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN, FISTULA.
Patient problems: Inadequate Osseointegration
MAUDE report 24159629 ↗InjuryJan 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 24129424 ↗InjuryJan 19, 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 24108020 ↗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 (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24051761 ↗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 ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24051264 ↗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 24051119 ↗InjuryJan 13, 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 24050910 ↗InjuryJan 12, 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 24035935 ↗InjuryJan 12, 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 24035406 ↗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 (B)(6) ARE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 24019705 ↗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 ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24019696 ↗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 24019491 ↗InjuryJan 8, 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 24002165 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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