SPI ELEMENT INICELL 4.23.552Recalls & 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 is a Thommen Medical SPI Element Inicell dental implant, a screw-shaped implant placed into the jawbone to replace a tooth. The reports mostly describe implants that fail to fuse with the surrounding bone, or that fuse and then lose that bond, with patients reporting pain, swelling and bone loss. There are 35 reports, all involving injuries and no deaths. 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
- 35
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 07640156470031), received between Feb 15, 2018 and Jul 8, 2026 — classified as 35 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (21 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 Osseointegrate21
- Loss of Osseointegration14
Patient problems
- Inadequate Osseointegration19
- No Code Available16
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN
Patient problems: Inadequate Osseointegration
MAUDE report 25744210 ↗InjuryJun 2, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION. PRIMARY STABILITY WAS ACHIEVED. IMPLANT WAS COMPLETELY COVERED WITH BONE. NO THREAD TAP USED. SWELLING.
Patient problems: Inadequate Osseointegration
MAUDE report 25357990 ↗InjuryJun 2, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SWELLING.
Patient problems: Inadequate Osseointegration
MAUDE report 25357861 ↗InjuryApr 13, 2026Failure to Osseointegrate
InjuryJan 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 24160312 ↗InjuryJan 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24160271 ↗InjuryOct 23, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, BONE RESORPTION.
Patient problems: Inadequate Osseointegration
MAUDE report 23365852 ↗InjurySep 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, BONE RESORPTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23073575 ↗InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, IMMEDIATE IMPLANTATION, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 21640495 ↗InjuryFeb 13, 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, PERIODONTAL DISEASE, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 21371953 ↗InjurySep 3, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20126271 ↗InjuryAug 16, 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, PERI-IMPLANTITIS
Patient problems: Inadequate Osseointegration
MAUDE report 19998222 ↗InjuryJul 5, 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, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 19679296 ↗InjuryJan 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED. (B)(4) ARE THE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 18501470 ↗InjuryJan 12, 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 18501396 ↗InjuryNov 23, 2022Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 15850346 ↗InjuryAug 26, 2022Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 15300170 ↗InjuryAug 26, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, INFECTION, PAIN, SWELLING.
Patient problems: Inadequate Osseointegration
MAUDE report 15300001 ↗InjuryOct 27, 2021Loss 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, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 12702587 ↗InjuryNov 16, 2020Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, TRAUMA/ACCIDENT, PAIN, INFLAMMATION. PATIENT STATES HE WAS EATING AND HEARD A CRACK. HE PRESENTS WITH PAIN, IMPLANT EVAL DONE. IMPLANTED WAS VERY LOOSE AND DENTIST REMOVED IT BY HAND.
Patient problems: No Code Available
MAUDE report 10842091 ↗InjuryOct 26, 2020Loss 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, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, PAIN, INFLAMMATION, MOBILITY.
Patient problems: No Code Available
MAUDE report 10732488 ↗InjuryOct 12, 2020Failure 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, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, PERHAPS INFECTION, INCREASED SENSITIVITY, SWELLING, BLEEDING. SAME PATIENT AS (B)(6).
Patient problems: No Code Available
MAUDE report 10660519 ↗InjurySep 30, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PAIN, MOBILITY.
Patient problems: No Code Available
MAUDE report 10604714 ↗InjurySep 28, 2020Failure 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 CAME BACK WITH THE IMPLANT IN HER HAND.
Patient problems: No Code Available
MAUDE report 10592260 ↗InjurySep 28, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFECTION, PAIN, SWELLING, ABSCESS, INFLAMMATION.
Patient problems: No Code Available
MAUDE report 10591668 ↗
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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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