SPI ELEMENT INICELL 4.23.546Recalls & 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
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07640156470048), received between Jun 23, 2018 and Jul 4, 2025 — classified as 8 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (7 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 Osseointegrate7
- Loss of Osseointegration1
Patient problems
- No Code Available7
- Inadequate Osseointegration1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJul 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, NO THREAD TAP USED, BLEEDING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22402354 ↗InjuryOct 12, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, BLOOD COAGULATION DISORDER, IMMEDIATE IMPLANTATION, INFECTION.
Patient problems: No Code Available
MAUDE report 10660649 ↗InjuryJul 6, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, INFECTION, PAIN, SWELLING, PUS.
Patient problems: No Code Available
MAUDE report 10231866 ↗InjuryNov 29, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, SMOKER, IMMEDIATE IMPLANTATION, MOBILITY. PROBABLY TOO LITTLE PRIMARY STABILITY AFTER IMMEDIATE IMPLANTATION, AS WELL AS PRESSURE ON VESTIBULAR CORTICALIS.
Patient problems: No Code Available
MAUDE report 9391577 ↗InjuryMay 27, 2019Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION, NO THREAD TAP USED, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED BY BONE, INFECTION, MOBILITY AT OPENING, SUSPENDING OSTITIS.
Patient problems: No Code Available
MAUDE report 8644060 ↗InjuryMay 27, 2019Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PATIENT HAS DIABETES MELLITUS, NO THREAD TAP USED, PRIMARY STABILITY WAS ACHIEVED, IMPLANT ACHIEVED OSSEOINTEGRATION, IMMEDIATE IMPLANTATION AND LOADING (BAR SUPPLY TO (B)(4)), MOBILITY. SAME PATIENT AS (B)(6).
Patient problems: No Code Available
MAUDE report 8644047 ↗InjuryFeb 4, 2019Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, IMPLANT WAS COMPLETELY COVERED BY BONE, IMMEDIATE IMPLANTATION, PAIN, INFLAMMATION, MOBILITY, DIABETES MELLITUS.
Patient problems: No Code Available
MAUDE report 8300645 ↗InjuryJun 23, 2018Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY ACHIEVED. BONE RESORPTION, FISTULA.
Patient problems: No Code Available
MAUDE report 7632369 ↗
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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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