SPI ELEMENT INICELL 4.23.113Recalls & 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
Quick summary
This Thommen SPI Element implant appears in 676 adverse event reports, with no deaths and 676 injuries. Reports mostly describe the implant not fusing with the jawbone, or later losing that bond, with patients reporting infection, pain and swelling. Reports fell in the last 12 months, to 45 from 82 in the 12 months before, and there are no recalls that name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 674
- Deaths reported
- 0
- Injuries reported
- 674
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 674 adverse event reports that list this exact device (DI 07640156471304), received between Jan 19, 2018 and Sep 28, 2026 — classified as 674 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (542 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.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate542
- Loss of Osseointegration127
- Loosening of Implant Not Related to Bone-Ingrowth2
- Device Handling Problem1
- Insufficient Device Problem Information1
- Patient-Device Incompatibility1
Patient problems
- Inadequate Osseointegration484
- No Code Available186
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Implant Pain1
Recent adverse event reports
The 25 most recent of 674 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, pain, swelling, bleeding, inflammation, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50911553 ↗InjurySep 14, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, pain, swelling, abscess.
Patient problems: Inadequate Osseointegration
MAUDE report 50753654 ↗InjuryAug 11, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, smoker, infection, pain, swelling, inflammation.
Patient problems: Inadequate Osseointegration
MAUDE report 50207229 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, peri-implantitis, swelling.
Patient problems: Inadequate Osseointegration
MAUDE report 50207138 ↗InjuryAug 10, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50191474 ↗InjuryAug 5, 2026Loss of Osseointegration
Loss of osseointegration, peri-implantitis.
Patient problems: Inadequate Osseointegration
MAUDE report 50140904 ↗InjuryJul 15, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25824383 ↗InjuryJul 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, SMOKER, PERIODONTAL DISEASE, PERI-IMPLANTITIS, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25812769 ↗InjuryJul 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INFLAMMATION, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 25746844 ↗InjuryJul 8, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 25744594 ↗InjuryJul 6, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25713673 ↗InjuryApr 29, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25025531 ↗InjuryApr 29, 2026Failure to Osseointegrate
InjuryApr 28, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, PAIN, SWELLING, BLEEDING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25015547 ↗InjuryApr 28, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, DIABETES MELLITUS, SMOKER, PERIODONTAL DISEASE, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25013867 ↗InjuryApr 27, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED - ANOTHER SIZE OF IMPLANT WAS CHOSEN.
Patient problems: Inadequate Osseointegration
MAUDE report 24997302 ↗InjuryApr 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24964525 ↗InjuryApr 22, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24952979 ↗InjuryApr 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PAIN, SWELLING, FISTULA, ABSCESS, BLEEDING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24857180 ↗InjuryApr 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24855836 ↗InjuryApr 8, 2026Failure to Osseointegrate
InjuryMar 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERI-IMPLANTITIS, PAIN, SWELLING, BLEEDING, INFLAMMATION ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24696177 ↗InjuryMar 23, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, DIABETES MELLITUS, SMOKER ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24660108 ↗InjuryMar 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PERI-IMPLANTITIS, PAIN, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24604061 ↗InjuryMar 6, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED.
Patient problems: Inadequate Osseointegration
MAUDE report 24528533 ↗
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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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