SPI CONTACT 4.13.223Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
All models of SPI CONTACT (18)
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 07640156471670), received between Jul 28, 2018 and Jun 23, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (2 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
- Loss of Osseointegration2
Patient problems
- Inadequate Osseointegration1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 25591087 ↗InjuryJul 28, 2018Loss of Osseointegration; Loss of Osseointegration
PRIMARY STABILITY AND OSSEOINTEGRATION ACHIEVED. BONE RESORPTION, INFLAMMATION, MOBILITY. LOSS OF IMPLANT.
Patient problems: No Code Available
MAUDE report 7729537 ↗
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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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