SPI ELEMENT INICELL 4.23.104Recalls & 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 is a Thommen Medical SPI Element Inicell dental implant, a root-shaped screw placed in the jawbone. The 50 reports mostly describe the implant failing to fuse with the surrounding bone, or losing that bond after surgery, in patients who smoke or have lost bone; reports also mention pain, swelling, bleeding, infection, and gum inflammation around the implant. All 50 reports involve injuries and none describe a death. 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
- 51
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 07640156478549), received between Nov 20, 2018 and Sep 28, 2026 — classified as 51 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (43 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 Osseointegrate43
- Loss of Osseointegration8
Patient problems
- Inadequate Osseointegration43
- No Code Available8
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
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 24052142 ↗InjuryJan 12, 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 24035599 ↗InjuryJan 9, 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 (B)(6) ARE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 24019734 ↗InjuryJan 6, 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, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 23972900 ↗InjuryAug 26, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PAIN, INFLAMMATION, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 22892549 ↗InjuryJan 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, PAIN ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 21239971 ↗InjuryJan 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, PAIN ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 21239963 ↗InjuryJan 7, 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, BLOOD COAGULATION DISORDER, PERI-IMPLANTITIS.
Patient problems: Inadequate Osseointegration
MAUDE report 21089606 ↗InjurySep 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20144693 ↗InjuryJun 24, 2024Loss 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, BONE RESORPTION.
Patient problems: Inadequate Osseointegration
MAUDE report 19592311 ↗InjuryJun 18, 2024Loss 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, PSYCHOLOGICAL DISORDER, SMOKER, PAIN, SWELLING, BLEEDING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 19556562 ↗InjuryJun 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, BRUXISM.
Patient problems: Inadequate Osseointegration
MAUDE report 19545565 ↗InjuryJun 4, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, DIABETES MELLITUS, SMOKER, PERIODONTAL DISEASE, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 19457216 ↗InjuryJun 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION
Patient problems: Inadequate Osseointegration
MAUDE report 19446671 ↗InjuryMay 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 19368873 ↗InjuryMay 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, MOBILITY. CONNECTIVE TISSUE SCAR AROUND IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 19267025 ↗InjuryFeb 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, DIABETES MELLITUS, SMOKER, PAIN, SWELLING.
Patient problems: Inadequate Osseointegration
MAUDE report 18682584 ↗InjuryFeb 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 18665974 ↗InjuryDec 22, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, PERHAPS ALCOHOL ABUSE, SMOKER, IMMEDIATE IMPLANTATION, PAIN, SWELLING, ABSCESS, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 18381498 ↗InjuryDec 20, 2023Failure 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, PERI-IMPLANTITIS.
Patient problems: Inadequate Osseointegration
MAUDE report 18362604 ↗InjuryNov 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 9, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, IMMEDIATE IMPLANTATION, INFECTION.
Patient problems: Inadequate Osseointegration
MAUDE report 17893501 ↗InjurySep 1, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, BIOMECHANICAL OVERLOAD, IMMEDIATE IMPLANTATION/LOAD, PAIN, INFLAMMATION, MOBILITY. TEMPORARY BRIDGE. (B)(6) ARE THE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 17668506 ↗InjurySep 1, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, BIOMECHANICAL OVERLOAD, IMMEDIATE IMPLANTATION/LOAD, PAIN, INFLAMMATION, MOBILITY. TEMPORARY BRIDGE. (B)(6) ARE THE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 17668496 ↗
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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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