SPI CONTACT INICELL 4.23.237Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640156470987), received between Mar 20, 2019 and Sep 3, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).
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.
Most reported problems
Device problems
- Failure to Osseointegrate1
- Loss of Osseointegration1
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2019Failure to Osseointegrate; Failure to Osseointegrate
NO THREAD TAP USED, PRIMARY STABILITY WAS ACHIEVED, IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, BONE RESORPTION.
Patient problems: No Code Available
MAUDE report 8954576 ↗InjuryMar 20, 2019Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION - PRIMARY STABILITY WAS ACHIEVED, IMPLANT SURFACE WAS COMPLETELY COVERED BY BONE, PERIODONTOSIS AT THE TIME OF SURGERY, PERIIMPLANTITIS, INCREASED SENSITIVITY.
Patient problems: No Code Available
MAUDE report 8435754 ↗
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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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