SPI ELEMENT INICELL 4.23.115Recalls & 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
Quick summary
This Thommen SPI Element dental implant has 202 adverse event reports, with 202 injuries and no deaths. Nearly all describe the implant failing to fuse with the bone or losing that bond, and some mention infection or pain. 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
- 203
- Deaths reported
- 0
- Injuries reported
- 203
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 203 adverse event reports that list this exact device (DI 07640156471281), received between Feb 23, 2018 and Sep 15, 2026 — classified as 203 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (164 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 Osseointegrate164
- Loss of Osseointegration35
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Inadequate Osseointegration128
- No Code Available74
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 203 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant wasn't completely covered with bone, pain, bleeding.
Patient problems: Inadequate Osseointegration
MAUDE report 50773844 ↗InjuryJul 10, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN, SWELLING
Patient problems: Inadequate Osseointegration
MAUDE report 25775573 ↗InjuryJul 10, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY - ANOTHER SIZE OF IMPLANT WAS CHOSEN (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 25775511 ↗InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INFECTION, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 25730058 ↗InjuryJun 1, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, DIABETES MELLITUS, COMPLICATION IN SITE PREPARATION, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25347797 ↗InjuryMar 23, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24660218 ↗InjuryMar 4, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, DIABETES MELLITUS, PERI-IMPLANTITIS, PAIN, ABSCESS.
Patient problems: Inadequate Osseointegration
MAUDE report 24510721 ↗InjuryMar 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INFECTION, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24504705 ↗InjuryFeb 25, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24441759 ↗InjuryFeb 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, DIABETES MELLITUS, IMMEDIATE IMPLANTATION, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, BLEEDING, INFLAMMATION (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24256754 ↗InjuryJan 29, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 24207970 ↗InjuryJan 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFECTION, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 24161110 ↗InjuryNov 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 23669487 ↗InjuryAug 27, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERI-IMPLANTITIS.
Patient problems: Inadequate Osseointegration
MAUDE report 22902868 ↗InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 22584766 ↗InjuryJul 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, INFECTION.
Patient problems: Inadequate Osseointegration
MAUDE report 22576233 ↗InjuryJun 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22334980 ↗InjuryMay 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22095385 ↗InjuryMay 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 21958915 ↗InjuryMar 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERI-IMPLANTITIS, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 21631612 ↗InjuryMar 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, SMOKER, INADEQUATE BONE QUALITY/QUANTITY, PRECEDING/SIMULTANEOUS BONE AUGMENTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 21524596 ↗InjuryFeb 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER.
Patient problems: Inadequate Osseointegration
MAUDE report 21443313 ↗InjuryJan 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 9, 2025Failure to Osseointegrate; Failure 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 21110798 ↗
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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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