SPI ELEMENT 4.13.920Recalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07640156471458), received between Feb 1, 2018 and Jul 21, 2024 — classified as 7 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (6 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 Osseointegrate6
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration5
- No Code Available2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19787987 ↗InjuryJul 18, 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, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 19769318 ↗InjuryJul 18, 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, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19769225 ↗InjuryJul 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19760872 ↗InjuryMar 6, 2023Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, IMMEDIATE IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 16484070 ↗InjuryMay 20, 2019Failure to Osseointegrate; Failure to Osseointegrate
SMOKER, THREAD TAP USED, IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WASN'T COMPLETELY COVERED BY BONE, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: No Code Available
MAUDE report 8622964 ↗InjuryFeb 1, 2018Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION, IMMEDIATE IMPLANTATION, INADEQUATE BONE QUALITY, SMOKER, INFECTION, SWELLING, PAIN
Patient problems: No Code Available
MAUDE report 7234438 ↗
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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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