SPI ELEMENT INICELL 4.23.536Recalls & 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 the Thommen SPI Element dental implant, a root-form endosseous implant. All 25 reports describe injuries, mostly cases where the implant failed to fuse with the jawbone or lost that fusion later, sometimes loosening or coming out entirely; no deaths were reported. 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
- 25
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07640156470093), received between Feb 2, 2018 and Mar 17, 2026 — classified as 25 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (23 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 Osseointegrate23
- Loss of Osseointegration2
Patient problems
- Inadequate Osseointegration18
- No Code Available7
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, PERI-IMPLANTITIS, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24617690 ↗InjurySep 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 20288614 ↗InjurySep 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 20245895 ↗InjuryApr 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 19049159 ↗InjuryFeb 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, SMOKER. PLACED WITH THREE OTHER IMPLANTS, ONE OTHER FAILED. WHEN REMOVING HEALING CAP, WHOLE IMPLANT CAME OUT.
Patient problems: Inadequate Osseointegration
MAUDE report 18628947 ↗InjuryJan 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, IMMEDIATE LOAD, INADEQUATE BONE QUALITY/QUANTITY, SIMULTANEOUS BONE AUGMENTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 18541344 ↗InjuryAug 11, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, SMOKER, PERIODONTAL DISEASE, SWELLING (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 17507650 ↗InjuryJul 26, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 17395011 ↗InjuryOct 14, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, IMMEDIATE IMPLANTATION, INFECTION, INCREASED SENSITIVITY, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 15603065 ↗InjuryAug 29, 2022Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, COMPLICATION IN SITE PREPARATION.
Patient problems: Inadequate Osseointegration
MAUDE report 15309242 ↗InjuryFeb 18, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 13557637 ↗InjuryNov 7, 2021Failure 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, IMMEDIATE IMPLANTATION. PATIENT STATED HE WAS TESTING THE IMPLANT BY CHEWING ON IT. UPON TORQUING ABUTMENT ON IMPLANT, THERE WAS PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 12758156 ↗InjuryOct 7, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, PAIN, SWELLING.
Patient problems: Inadequate Osseointegration
MAUDE report 12588036 ↗InjurySep 6, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 12427993 ↗InjuryJun 22, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, UNDERSIZED IMPLANT BED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 12040409 ↗InjuryApr 27, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, DIABETES MELLITUS, SMOKER, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 11730364 ↗InjuryApr 27, 2021Failure 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, PERIODONTAL DISEASE, IMMEDIATE IMPLANTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 11730271 ↗InjuryMar 19, 2021Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY. SAME PATIENT AS (B)(6).
Patient problems: Inadequate Osseointegration
MAUDE report 11523832 ↗InjuryDec 1, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, IMMEDIATE LOADING.
Patient problems: No Code Available
MAUDE report 10926355 ↗InjuryDec 1, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 3, 2019Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION, NO THREAD TAP USED, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED BY BONE, BAD BONE CONDITIONS.
Patient problems: No Code Available
MAUDE report 8577382 ↗InjuryMar 15, 2019Failure to Osseointegrate; Failure to Osseointegrate
NO PRIMARY STABILITY, IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WASN'T COMPLETELY COVERED BY BONE, INADEQUATE BONE QUALITY/QUANTITY, ASYMPTOMATIC.
Patient problems: No Code Available
MAUDE report 8423839 ↗InjurySep 13, 2018Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY ACHIEVED, NO OSSEOINTEGRATION. EARLY LOSS.
Patient problems: No Code Available
MAUDE report 7872518 ↗InjuryFeb 15, 2018Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE, INADEQUATE BONE, PAIN, BONE RESORPTION, INFECTION (SAME PATIENT AS (B)(6).
Patient problems: No Code Available
MAUDE report 7273367 ↗InjuryFeb 2, 2018Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION, INFECTION, INFLAMMATION, SMOKER.
Patient problems: No Code Available
MAUDE report 7236616 ↗
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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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