SPI CONTACT INICELL 4.23.226Recalls & 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
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07640156471038), received between Mar 6, 2018 and Nov 28, 2025 — classified as 16 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (12 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 Osseointegrate12
- Loss of Osseointegration4
Patient problems
- No Code Available9
- Inadequate Osseointegration7
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryNov 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 23670647 ↗InjuryAug 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22849234 ↗InjurySep 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAPE USED, DIABETES MELLITUS TYPE II, PSYCHOLOGICAL DISORDER, SMOKER, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 20320844 ↗InjuryMay 17, 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 19339738 ↗InjuryMar 9, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED.
Patient problems: Inadequate Osseointegration
MAUDE report 13709929 ↗InjuryMar 9, 2022Loss 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 13706214 ↗InjuryDec 7, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 12950468 ↗InjurySep 14, 2020Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, SMOKER, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, IMMEDIATE IMPLANTATION, BONE RESORPTION, INFECTION ((B)(6) ARE SAME PATIENT).
Patient problems: No Code Available
MAUDE report 10527686 ↗InjuryMar 21, 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 9863285 ↗InjuryNov 19, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, PERI-IMPLANTITIS.
Patient problems: No Code Available
MAUDE report 9340426 ↗InjurySep 2, 2019Loss 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, SMOKER, IMMEDIATE IMPLANTATION, SUB ACUTE INFLAMMATION.
Patient problems: No Code Available
MAUDE report 8953526 ↗InjuryFeb 22, 2019Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION, NO THREAD TAP USED, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED BY BONE.
Patient problems: No Code Available
MAUDE report 8360816 ↗InjuryDec 15, 2018Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION. IMMEDIATE PLACEMENT AFTER EXTRACTION. PERI-IMPLANTITIS, INFLAMMATION, INFECTION, INADEQUATE BONE QUALITY.
Patient problems: No Code Available
MAUDE report 8167613 ↗InjuryDec 15, 2018Loss of Osseointegration; Loss of Osseointegration
IMPLANT LOSS. IMMEDIATE IMPLANTATION AND IMMEDIATE LOADING. INFECTION, INADEQUATE BONE QUALITY / QUANTITY, PAIN, BIOMECHANICAL OVERLOAD.
Patient problems: No Code Available
MAUDE report 8167559 ↗InjurySep 22, 2018Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY ACHIEVED, NO OSSEOINTEGRATION. PATIENT WAS SMOKING. DIABETES MELLITUNS. IMMEDIATE IMPLANTATION. MOBILITY.
Patient problems: No Code Available
MAUDE report 7900458 ↗InjuryMar 6, 2018Failure to Osseointegrate; Failure to Osseointegrate
NO PRIMARY STABILITY, INADEQUATE BONE QUALITY (SOFT BONE). SAME PATIENT AS (B)(4).
Patient problems: No Code Available
MAUDE report 7316854 ↗
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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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