SPI ELEMENT INICELL 4.23.533Recalls & 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 is a screw-shaped dental implant placed into bone during dental surgery. Most of the 313 reports describe the implant failing to bond with the bone or losing that bond, and some mention infection or mobility. There were 313 injury reports and no deaths, and no recalls 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
- 313
- Deaths reported
- 0
- Injuries reported
- 313
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 313 adverse event reports that list this exact device (DI 07640156470123), received between Feb 2, 2018 and Sep 15, 2026 — classified as 313 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (242 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 Osseointegrate242
- Loss of Osseointegration66
- Break3
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Inadequate Osseointegration208
- No Code Available102
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
Recent adverse event reports
The 25 most recent of 313 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Loss of Osseointegration
Loss of osseointegration, pain, bleeding, mobility ((b)(6) and (b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50772527 ↗InjurySep 15, 2026Loss of Osseointegration
Loss of osseointegration, pain, bleeding, mobility (2026_1856 and 1857 are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50772508 ↗InjuryJun 3, 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 25370432 ↗InjuryJun 2, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, BRUXISM, PAIN, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25359900 ↗InjuryJun 2, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 25359589 ↗InjuryJun 2, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SWELLING.
Patient problems: Inadequate Osseointegration
MAUDE report 25359276 ↗InjuryJun 2, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SWELLING.
Patient problems: Inadequate Osseointegration
MAUDE report 25357952 ↗InjuryJun 1, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, ABSCESS, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25345823 ↗InjuryMay 29, 2026Failure to Osseointegrate
InjuryMay 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, DIABETES MELLITUS, PERI-IMPLANTITIS, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25313571 ↗InjuryMay 27, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PERI-IMPLANTITIS, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25299452 ↗InjuryMay 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, DIABETES MELLITUS, SMOKER, PERIODONTAL DISEASE, PAIN, ABSCESS, BLEEDING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25214919 ↗InjuryMay 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER.
Patient problems: Inadequate Osseointegration
MAUDE report 25214903 ↗InjuryMay 19, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25214814 ↗InjuryApr 29, 2026Failure to Osseointegrate
InjuryApr 29, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, SMOKER.
Patient problems: Inadequate Osseointegration
MAUDE report 25025199 ↗InjuryApr 28, 2026Failure to Osseointegrate
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25013667 ↗InjuryApr 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24872823 ↗InjuryApr 13, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, IMMEDIATE IMPLANTATION - ANOTHER SIZE OF IMPLANT WAS CHOSEN.
Patient problems: Inadequate Osseointegration
MAUDE report 24855779 ↗InjuryMar 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, BONE RESORPTION, PERI-IMPLANTITIS, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24604439 ↗InjuryMar 6, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, ABSCESS.
Patient problems: Inadequate Osseointegration
MAUDE report 24528634 ↗InjuryFeb 27, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, PERIODONTAL DISEASE, PAIN, BLEEDING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24467191 ↗InjuryJan 30, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24219606 ↗InjuryJan 26, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, COMPROMISED IMMUNE RESISTANCE, SMOKER, BONE RESORPTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24176480 ↗InjuryJan 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, ABSCESS, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 24158804 ↗
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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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