SPI ELEMENT 4.13.950Recalls & 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 SPI ELEMENT 4.13.950 endosseous, root-form dental implant placed into the jawbone. Most of the 36 reports describe the implant failing to fuse with the surrounding bone, or later losing that fusion, which left it loose and led to pain, inflammation and infection. All 36 reports involved injuries, with no deaths. There are no recalls naming this device, and no reports were filed in the past 12 months.
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
- 36
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 07640156471342), received between Dec 15, 2018 and May 12, 2025 — classified as 36 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (31 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 Osseointegrate31
- Loss of Osseointegration5
Patient problems
- Inadequate Osseointegration22
- No Code Available14
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
InjuryMay 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PAIN, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22000584 ↗InjuryMar 27, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, INFECTION, PAIN, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 21704895 ↗InjuryMar 27, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 21704829 ↗InjuryAug 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 19990002 ↗InjuryAug 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 19989999 ↗InjuryAug 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 19989472 ↗InjuryJun 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMMEDIATE IMPLANTATION, UNDERSIZED IMPLANT BED, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19457584 ↗InjuryMay 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION.
Patient problems: Inadequate Osseointegration
MAUDE report 19378968 ↗InjuryJan 22, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, FISTULA, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 18551803 ↗InjuryJul 13, 2023Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, UNDERSIZED IMPLANT BED.
Patient problems: Inadequate Osseointegration
MAUDE report 17314293 ↗InjuryJun 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, FISTULA, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 17223387 ↗InjuryJun 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMMEDIATE IMPLANTATION, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 17223377 ↗InjuryJun 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PAIN, FISTULA ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 17150735 ↗InjuryJan 31, 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, PERIODONTAL DISEASE, INFECTION, PAIN, SWELLING, ABSCESS (B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 16270774 ↗InjuryNov 11, 2022Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED. ANOTHER IMPLANT WITH PF 4.0 HAS BEEN PLACED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 15779196 ↗InjuryMar 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 13692070 ↗InjuryMar 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 13691779 ↗InjuryFeb 24, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, PAIN, SWELLING, INFLAMMATION, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 13589970 ↗InjuryFeb 23, 2022Failure 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, BONE RESORPTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 13582810 ↗InjuryDec 12, 2021Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, INADEQUATE BONE QUALITY/QUANTITY
Patient problems: Inadequate Osseointegration
MAUDE report 12981948 ↗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, INFECTION, PAIN ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 12438246 ↗InjuryApr 14, 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, IMMEDIATE IMPLANTATION, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 11663907 ↗InjuryAug 2, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, COMPLICATION IN SITE PREPARATION, INFECTION, PAIN, SWELLING, BLEEDING, MOBILITY.
Patient problems: No Code Available
MAUDE report 10354166 ↗InjuryJul 31, 2020Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, ANOTHER DIAMETER WAS CHOSEN.
Patient problems: No Code Available
MAUDE report 10349286 ↗InjuryJul 26, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT HAD TO BE REMOVED DUE TO PAIN, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, LOCAL INFECTION/SUBACUTE CHRONIC OSTEITIS, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, INFECTION, PAIN, SWELLING, ABSCESS, INFLAMMATION OF USED AUGMENTATION MATERIAL.
Patient problems: No Code Available
MAUDE report 10324387 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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