SPI CONTACT INICELL 4.23.236Recalls & 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
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07640156470994), received between Mar 16, 2018 and Feb 3, 2026 — classified as 22 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (21 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 Osseointegrate21
- Loss of Osseointegration1
- Unstable1
Patient problems
- Inadequate Osseointegration14
- No Code Available8
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER, PERIODONTAL DISEASE, PAIN ((B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 24244967 ↗InjuryFeb 3, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER, PERIODONTAL DISEASE, PAIN (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24244962 ↗InjuryFeb 3, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER, PERIODONTAL DISEASE, PAIN ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24244956 ↗InjurySep 17, 2025Failure 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 23074009 ↗InjurySep 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 22975953 ↗InjurySep 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 20246248 ↗InjurySep 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 20245943 ↗InjuryJun 7, 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 19482045 ↗InjuryFeb 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 18766928 ↗InjuryAug 28, 2023Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, SMOKER.
Patient problems: Inadequate Osseointegration
MAUDE report 17630872 ↗InjuryMay 23, 2023Failure 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 16982997 ↗InjuryApr 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 16762136 ↗InjuryMar 29, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 13938100 ↗InjuryNov 20, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 14, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS, PAIN, INCREASED SENSITIVITY.
Patient problems: No Code Available
MAUDE report 10676735 ↗InjuryOct 6, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, BONE RESORPTION, PAIN, SWELLING, MOBILITY.
Patient problems: No Code Available
MAUDE report 10634077 ↗InjuryJul 20, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY.
Patient problems: No Code Available
MAUDE report 10294751 ↗InjuryJul 28, 2018Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY ACHIEVED, NO OSSEOINTEGRATION. MOBILITY.
Patient problems: No Code Available
MAUDE report 7729561 ↗InjuryJun 23, 2018Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 5, 2018Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY ACHIEVED, NO OSSEOINTEGRATION. INSTABILITY.
Patient problems: No Code Available
MAUDE report 7489287 ↗InjuryMar 20, 2018Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 16, 2018Unstable; Loss of Osseointegration
PRIMARY STABILITY ACHIEVED, INSTABILITY, LOSS OF OSSEOINTEGRATION.
Patient problems: No Code Available
MAUDE report 7345451 ↗
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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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