SPI ELEMENT INICELL 4.23.526Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
All models of SPI ELEMENT INICELL (67)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Thommen Medical SPI ELEMENT Inicell dental implant is a root-form screw implant placed in the jawbone. The 32 reports mostly describe the implant failing to fuse with the surrounding bone, sometimes with pain, swelling, infection or mobility, and all 32 involved injuries, with no deaths. The reports mention factors like smoking, poor bone quality, steroid-related illness and heavy bite forces. 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
- 32
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 07640156470154), received between Sep 22, 2018 and Jul 10, 2026 — classified as 32 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (23 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate23
- Loss of Osseointegration9
Patient problems
- Inadequate Osseointegration18
- No Code Available14
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
InjuryJul 10, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, SMOKER, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 25776223 ↗InjuryJun 2, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMMEDIATE IMPLANTATION (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25360098 ↗InjuryMay 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, ILLNESS REQUIRING STEROIDS, UNCONTROLLED ENDOCRINE ILLNESS, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, INFECTION, PAIN, SWELLING, ABSCESS.
Patient problems: Inadequate Osseointegration
MAUDE report 25214842 ↗InjuryFeb 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24412581 ↗InjuryFeb 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 24412524 ↗InjuryJun 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, BIOMECHANICAL OVERLOAD, IMMEDIATE IMPLANTATION, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22200877 ↗InjuryFeb 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 21320123 ↗InjuryJun 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, IMMEDIATE IMPLANTATION, PAIN, SWELLING.
Patient problems: Inadequate Osseointegration
MAUDE report 19557429 ↗InjuryFeb 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER.
Patient problems: Inadequate Osseointegration
MAUDE report 18720267 ↗InjuryDec 8, 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, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 18289662 ↗InjurySep 22, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 14, 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, MOBILITY. 2-3 MONTHS POST PLACEMENT. PATIENT LOST TWO OTHERS EARLY.
Patient problems: Inadequate Osseointegration
MAUDE report 17323510 ↗InjuryJun 14, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, TRAUMA / ACCIDENT, PAIN, BLEEDING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 17124687 ↗InjuryMay 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, XEROSTOMIA, SMOKER, PERIODONTAL DISEASE, IMMEDIATE IMPLANTATION, PAIN, INFLAMMATION, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 16918459 ↗InjuryMay 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, XEROSTOMIA, SMOKER, PERIODONTAL DISEASE, IMMEDIATE IMPLANTATION, PAIN, INFLAMMATION, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 16918455 ↗InjurySep 28, 2021Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED - ANOTHER SIZE OF IMPLANT WAS CHOSEN.
Patient problems: Inadequate Osseointegration
MAUDE report 12540695 ↗InjuryMay 18, 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, IMMEDIATE IMPLANTATION, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 11839812 ↗InjuryApr 27, 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, PERIODONTAL DISEASE, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 11730396 ↗InjuryOct 1, 2020Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMMEDIATE IMPLANTATION, MOBILITY. ((B)(6) ARE SAME PATIENT).
Patient problems: No Code Available
MAUDE report 10612188 ↗InjurySep 30, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, NERVE ENCROACHMENT, NUMBNESS.
Patient problems: No Code Available
MAUDE report 10605310 ↗InjurySep 21, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, INFECTION, INFLAMMATION PROBABLY DUE TO AN INSUFFICIENT NEIGHBORING TOOTH.
Patient problems: No Code Available
MAUDE report 10559114 ↗InjuryJul 6, 2020Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION.
Patient problems: No Code Available
MAUDE report 10231491 ↗InjuryMar 11, 2020Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, THREAD TAP USED, DIABETES MELLITUS, IMMEDIATE IMPLANTATION ((B)(6) ARE SAME PATIENT).
Patient problems: No Code Available
MAUDE report 9817286 ↗InjuryFeb 5, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, PERIODONTAL DISEASE, BONE RESORPTION, PAIN, MOBILITY.
Patient problems: No Code Available
MAUDE report 9669518 ↗InjuryJan 20, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMMEDIATE IMPLANTATION, MOBILITY. CONDITION AFTER IMMEDIATE IMPLANTATION AND POSSIBLY AN UNDETECTED INFLAMMATORY PROCESS PRESENT.
Patient problems: No Code Available
MAUDE report 9605177 ↗
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page