SPI ELEMENT 4.13.906Recalls & 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
Quick summary
This is a Thommen Medical dental implant, a screw-shaped root-form implant used to replace missing teeth. The 64 reports mostly describe the implant failing to fuse with the surrounding bone, or losing that fusion over time, which can leave it loose, sometimes alongside infection, sinus perforation, or gum disease. All 64 reports describe injuries, with no deaths. There are no recalls naming 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
- 64
- Deaths reported
- 0
- Injuries reported
- 64
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 07640156470840), received between Apr 27, 2018 and Jan 29, 2026 — classified as 64 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (49 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 Osseointegrate49
- Loss of Osseointegration15
Patient problems
- Inadequate Osseointegration45
- No Code Available19
Recent adverse event reports
The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, PERIODONTAL DISEASE, SINUS PERFORATION, INFECTION, ABSCESS, INFLAMMATION, AND MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24209710 ↗InjuryJun 12, 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, SMOKER, PERIODONTAL DISEASE, BONE RESORPTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22191830 ↗InjuryMay 12, 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, SMOKER, PERIODONTAL DISEASE, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22003272 ↗InjuryNov 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20805578 ↗InjuryNov 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 20804832 ↗InjuryNov 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, BLOOD COAGULATION DISORDER, DIABETES MELLITUS, SMOKER.
Patient problems: Inadequate Osseointegration
MAUDE report 20721481 ↗InjuryNov 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, BLOOD COAGULATION DISORDER.
Patient problems: Inadequate Osseointegration
MAUDE report 20721360 ↗InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, DIABETES MELLITUS, PERI-IMPLANTITIS, PAIN, FISTULA, ABSCESS.
Patient problems: Inadequate Osseointegration
MAUDE report 20629093 ↗InjuryNov 7, 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
Patient problems: Inadequate Osseointegration
MAUDE report 20628964 ↗InjuryOct 24, 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, SMOKER, PERI-IMPLANTITIS, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20521368 ↗InjuryOct 23, 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, SWELLING, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 20512751 ↗InjuryJun 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 23, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, PERI-IMPLANTITIS, SWELLING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19379068 ↗InjuryMay 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 19378956 ↗InjuryMay 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 19371994 ↗InjuryMay 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 19368893 ↗InjuryDec 18, 2023Failure 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 18344574 ↗InjuryNov 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, DIABETES MELLITUS, SMOKER, PERIODONTAL DISEASE.
Patient problems: Inadequate Osseointegration
MAUDE report 18169587 ↗InjuryNov 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 18128594 ↗InjuryNov 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION.
Patient problems: Inadequate Osseointegration
MAUDE report 18128492 ↗InjuryJul 13, 2023Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, NUMBNESS.
Patient problems: Inadequate Osseointegration
MAUDE report 17313891 ↗InjuryJul 12, 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, INFECTION, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 17306357 ↗InjuryJun 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PERI-IMPLANTITIS, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 17223048 ↗
Other Implant, Endosseous, Root-Form devices
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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