SPI ELEMENT INICELL 4.23.155Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
All models of SPI ELEMENT INICELL (67)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640156470734), received between Jun 30, 2018 and Jun 28, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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
- Failure to Osseointegrate2
- Loss of Osseointegration1
Patient problems
- No Code Available2
- Inadequate Osseointegration1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, UNCONTROLLED DIABETES MELLITUS, IMMEDIATE IMPLANTATION, INADEQUATE BONE QUALITY/QUANTITY, INFLAMMATION, MOBILITY. MM2024_1945 AND 2024_1946 ARE THE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 19631008 ↗InjurySep 22, 2018Loss of Osseointegration; Loss of Osseointegration
PRIMARY STABILITY AND OSSEOINTEGRATION ACHIEVED. PERI-IMPLANTITIS, INFLAMMATION, MOBILITY.
Patient problems: No Code Available
MAUDE report 7900419 ↗InjuryJun 30, 2018Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY ACHIEVED, NO OSSEOINTEGRATION. SWELLING, INFLAMMATION, MOBILITY. THE IMPLANT WAS NOT LOADED. WAS PLACED 7 WEEKS AFTER FAILURE TOOTH WAS EXTRACTED. PATIENT HAS EXCELLENT BONE. SURGEON GUESSES THERE WAS SOME RESIDUAL INFECTION. THAT'S THE ONLY THING HE CAN FIGURE. THIS WAS NOT A HIGH RISK PLACEMENT.
Patient problems: No Code Available
MAUDE report 7653803 ↗
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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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