SPI ELEMENT INICELL 4.23.714Recalls & 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
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07640156470291), received between Apr 21, 2018 and May 19, 2026 — classified as 11 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (11 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 Osseointegrate11
Patient problems
- Inadequate Osseointegration7
- No Code Available4
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, IMMEDIATE IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25214809 ↗InjuryAug 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER, INFECTION, PAIN (B)(6), ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 22736528 ↗InjuryJun 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 19497331 ↗InjuryAug 25, 2023Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, THREAD TAP USED, SMOKER. ANOTHER IMPLANT RC HAS BEEN PLACED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 17622517 ↗InjuryAug 16, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 15233164 ↗InjuryMar 29, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERIODONTAL DISEASE, INFECTION.
Patient problems: Inadequate Osseointegration
MAUDE report 13938178 ↗InjuryNov 23, 2021Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, BLOOD COAGULATION DISORDER, BRUXISM (2021_2059 AND 2021_2060 ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 12858983 ↗InjuryNov 11, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, DIABETES MELLITUS, XEROSTOMIA, IMMEDIATE IMPLANTATION, PAIN, SWELLING, ABSCESS, INFLAMMATION, MOBILITY. AFTER IMPLANT PLACEMENT PATIENT HAD PAIN AND SWELLING. FOR 2 WEEKS, FINAL RESULT REMOVAL.
Patient problems: No Code Available
MAUDE report 9303921 ↗InjurySep 2, 2019Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 8, 2019Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED BY BONE.
Patient problems: No Code Available
MAUDE report 8319370 ↗InjuryApr 21, 2018Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY ACHIEVED, NO OSSEOINTEGRATION, PAIN, INSTABILITY.
Patient problems: No Code Available
MAUDE report 7449420 ↗
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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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