SPI ELEMENT INICELL 4.23.112Recalls & 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 INICELL dental implant is a root-form implant placed in the jawbone. Most of its 401 adverse event reports describe the implant failing to fuse with the bone or later losing that bond, and many note that no thread tap was used. The reports list 401 injuries 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
- 398
- Deaths reported
- 0
- Injuries reported
- 398
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 398 adverse event reports that list this exact device (DI 07640156472967), received between Jan 22, 2018 and Aug 28, 2026 — classified as 398 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (311 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 Osseointegrate311
- Loss of Osseointegration83
- Loosening of Implant Not Related to Bone-Ingrowth3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Inadequate Osseointegration294
- No Code Available101
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
Recent adverse event reports
The 25 most recent of 398 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, no thread tap used, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50492450 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration, primary stability was achieved, implant was completely covered with bone, swelling, bleeding, mobility ((b)(6) and (b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50471468 ↗InjuryAug 11, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, implant was completely covered with bone, no thread tap used.
Patient problems: Inadequate Osseointegration
MAUDE report 50207160 ↗InjuryJul 15, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 25824492 ↗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, DIABETES MELLITUS, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25824486 ↗InjuryJul 8, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION. PRIMARY STABILITY WAS ACHIEVED. IMPLANT WAS COMPLETELY COVERED WITH BONE. NO THREAD TAP USED. DIABETES MELLITUS. MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25743803 ↗InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25729423 ↗InjuryJul 6, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PAIN, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25713662 ↗InjuryJun 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, PERI-IMPLANTITIS, PAIN, MOBILITY (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25590639 ↗InjuryJun 23, 2026Failure to Osseointegrate
InjuryJun 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SWELLING, FISTULA, BLEEDING, INFLAMMATION, MOBILITY ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25370959 ↗InjuryMay 19, 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 25214811 ↗InjuryApr 29, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25025573 ↗InjuryApr 28, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, PERI-IMPLANTITIS, PAIN, FISTULA.
Patient problems: Inadequate Osseointegration
MAUDE report 25016230 ↗InjuryApr 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, SWELLING, BLEEDING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24857350 ↗InjuryApr 13, 2026Loss of Osseointegration
InjuryApr 10, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, OVERHEATING OF BONE.
Patient problems: Inadequate Osseointegration
MAUDE report 24843507 ↗InjuryMar 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, PERIODONTAL DISEASE, PERI-IMPLANTITIS, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 24661986 ↗InjuryMar 23, 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, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 24661513 ↗InjuryMar 6, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24528491 ↗InjuryMar 4, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, BIOMECHANICAL OVERLOAD.
Patient problems: Inadequate Osseointegration
MAUDE report 24511494 ↗InjuryFeb 27, 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 24466468 ↗InjuryFeb 20, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24399276 ↗InjuryFeb 4, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, DIABETES MELLITUS, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24256229 ↗InjuryJan 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PAIN, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 24221944 ↗
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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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