SPI CONTACT 4.13.232Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
All models of SPI CONTACT (18)
Data updated Oct 16, 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 07640156471632), received between Sep 29, 2018 and Jan 14, 2022 — classified as 5 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (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 16, 2026.
Most reported problems
Device problems
- Loss of Osseointegration5
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.
InjuryJan 14, 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, PSYCHOLOGICAL DISORDER, PAIN, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 13257038 ↗InjuryJan 18, 2021Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 11184176 ↗InjuryJan 13, 2021Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, NO THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 11163156 ↗InjuryMar 20, 2019Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION - PRIMARY STABILITY WAS ACHIEVED, IMPLANT SURFACE WAS COMPLETELY COVERED BY BONE, BLOOD COAGULATION DISORDER, INCREASED SENSITIVITY, INFLAMMATION.
Patient problems: No Code Available
MAUDE report 8435730 ↗InjurySep 29, 2018Loss of Osseointegration; Loss of Osseointegration
PRIMARY STABILITY AND OSSEOINTEGRATION ACHIEVED. BONE RESORPTION AND LOSS.
Patient problems: No Code Available
MAUDE report 7921119 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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