SPI CONTACT INICELL 4.23.246Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640156470949), received between Jul 28, 2018 and Aug 28, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (5 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 Osseointegrate5
Patient problems
- Inadequate Osseointegration3
- No Code Available2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2026Failure to Osseointegrate
Primary stability not achieved, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50491710 ↗InjuryJun 7, 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 19490884 ↗InjuryApr 1, 2022Failure 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 13974980 ↗InjuryDec 15, 2018Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY ACHIEVED, NO OSSEOINTEGRATION. MOBILITY.
Patient problems: No Code Available
MAUDE report 8167621 ↗InjuryJul 28, 2018Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY ACHIEVED, NO OSSEOINTEGRATION. MOBILITY.
Patient problems: No Code Available
MAUDE report 7729609 ↗
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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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