SPI ELEMENT 4.13.907Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
All models of SPI ELEMENT (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07640156470833), received between Mar 25, 2019 and Jun 15, 2026 — classified as 20 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (15 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 Osseointegrate15
- Loss of Osseointegration5
Patient problems
- Inadequate Osseointegration17
- No Code Available3
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, SMOKER, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25503427 ↗InjuryMar 20, 2026Loss of Osseointegration
InjuryJun 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22319596 ↗InjuryFeb 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, BONE RESORPTION, PERI-IMPLANTITIS, PAIN, SWELLING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 21443556 ↗InjuryOct 30, 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.
Patient problems: Inadequate Osseointegration
MAUDE report 20564654 ↗InjuryJun 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE.
Patient problems: Inadequate Osseointegration
MAUDE report 19458010 ↗InjuryMay 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 19369386 ↗InjuryMay 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19369247 ↗InjuryMay 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 19368880 ↗InjuryOct 23, 2023Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, BONE RESORPTION.
Patient problems: Inadequate Osseointegration
MAUDE report 17984438 ↗InjuryOct 2, 2023Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, A LONGER IMPLANT HAS BEEN PLACED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 17850507 ↗InjuryApr 28, 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, INADEQUATE BONE QUALITY/QUANTITY, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 16830337 ↗InjuryJan 12, 2023Loss 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, PERIODONTAL DISEASE, BONE RESORPTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 16146070 ↗InjuryNov 6, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, PERIODONTAL DISEASE, INFECTION, PAIN, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 15741116 ↗InjuryAug 28, 2022Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, MOBILITY - ANOTHER SIZE OF IMPLANT WAS CHOSEN.
Patient problems: Inadequate Osseointegration
MAUDE report 15307792 ↗InjurySep 8, 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, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 12437392 ↗InjuryApr 19, 2021Failure 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 11683677 ↗InjuryJul 20, 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, SMOKER, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY. THE DENTIST IMMEDIATELY NOTICED A POOR BONE QUALITY AND CONSEQUENTLY A LOW STABILITY.
Patient problems: No Code Available
MAUDE report 10294000 ↗InjuryFeb 12, 2020Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: No Code Available
MAUDE report 9697729 ↗InjuryMar 25, 2019Loss of Osseointegration; Loss of Osseointegration
LOSS OF IMPLANT - PERI-IMPLANTITIS, PAIN, SWELLING, DENTIST SPLIT CROWN, IMPLANT FAILED.
Patient problems: No Code Available
MAUDE report 8447940 ↗
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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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