SPI ELEMENT INICELL 4.23.715Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
All models of SPI ELEMENT INICELL (67)
Data updated Oct 16, 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 07640156470277), received between Aug 11, 2018 and Nov 23, 2021 — classified as 3 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 16, 2026.
Most reported problems
Device problems
- Loss of Osseointegration2
- Failure to Osseointegrate1
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.
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 12858975 ↗InjuryAug 11, 2018Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION. MOBILITY. SAME PATIENT AS (B)(6).
Patient problems: No Code Available
MAUDE report 7775130 ↗InjuryAug 11, 2018Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION. MOBILITY. SAME PATIENT AS (B)(6).
Patient problems: No Code Available
MAUDE report 7775128 ↗
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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 13, 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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