SPI ELEMENT INICELL 4.23.542Recalls & 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 is placed in the jawbone to support a replacement tooth. Its 191 reports mostly describe implants that failed to bond with the bone or later lost that bond, and some note looseness, infection, pain or bleeding. Some reports mention smoking, diabetes or gum disease. There are 191 injury reports and no deaths. No recalls name this device. Reports fell from 28 in the year before to 19 in the latest year.
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
- 191
- Deaths reported
- 0
- Injuries reported
- 191
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 191 adverse event reports that list this exact device (DI 07640156470086), received between Jan 18, 2018 and Aug 27, 2026 — classified as 191 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (141 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 Osseointegrate141
- Loss of Osseointegration48
- Adverse Event Without Identified Device or Use Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Inadequate Osseointegration131
- No Code Available59
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 191 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant wasn't completely covered with bone, thread tap used, smoker, inadequate bone quality/quantity.
Patient problems: Inadequate Osseointegration
MAUDE report 50469916 ↗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, periodontal disease.
Patient problems: Inadequate Osseointegration
MAUDE report 50207691 ↗InjuryJun 5, 2026Failure to Osseointegrate
InjuryMay 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, DIABETES MELLITUS, INFECTION, PAIN, SWELLING, BLEEDING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25315315 ↗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, BRUXISM, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25214941 ↗InjuryMay 19, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERIODONTAL DISEASE, COMPLICATION IN SITE PREPARATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25214908 ↗InjuryFeb 27, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, BONE RESORPTION, PERI-IMPLANTITIS.
Patient problems: Inadequate Osseointegration
MAUDE report 24467012 ↗InjuryFeb 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24412683 ↗InjuryFeb 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24412595 ↗InjuryFeb 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, BONE RESORPTION, PERI-IMPLANTITIS.
Patient problems: Inadequate Osseointegration
MAUDE report 24412553 ↗InjuryFeb 20, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, PAIN, SWELLING, INFLAMMATION, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24399549 ↗InjuryFeb 3, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, SMOKER, IMMEDIATE IMPLANTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24245095 ↗InjuryJan 30, 2026Failure to Osseointegrate
InjuryJan 26, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, DIABETES MELLITUS, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24177668 ↗InjuryJan 21, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN, SWELLING.
Patient problems: Inadequate Osseointegration
MAUDE report 24129466 ↗InjuryJan 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, UNCONTROLLED ENDOCRINE ILLNESS, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24128923 ↗InjuryJan 13, 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 24051669 ↗InjuryJan 8, 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 24001643 ↗InjuryNov 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23508602 ↗InjuryOct 27, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, BIOMECHANICAL OVERLOAD, BRUXISM, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23388692 ↗InjurySep 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, SMOKER, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23093639 ↗InjuryAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22892835 ↗InjuryAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22892828 ↗InjuryAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22892806 ↗InjuryAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22892792 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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