SPI ELEMENT INICELL 4.23.523Recalls & 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 SPI Element Inicell is a root-form implant placed into the bone. Its 404 adverse event reports often describe the implant failing to fuse with the bone, and some mention poor initial stability. The reports include no deaths and 404 injuries. No recalls name 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
- 405
- Deaths reported
- 0
- Injuries reported
- 405
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 405 adverse event reports that list this exact device (DI 07640156470215), received between Feb 2, 2018 and Sep 15, 2026 — classified as 405 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (301 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 Osseointegrate301
- Loss of Osseointegration103
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Inadequate Osseointegration303
- No Code Available100
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 25 most recent of 405 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Failure to Osseointegrate
InjurySep 14, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant was completely covered with bone, infection, pain, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50753780 ↗InjuryAug 27, 2026Failure to Osseointegrate
Primary stability not achieved, implant wasn't completely covered with bone, no thread tap used.
Patient problems: Inadequate Osseointegration
MAUDE report 50469320 ↗InjuryJul 14, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 25811924 ↗InjuryJun 2, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, IMMEDIATE IMPLANTATION, INFECTION, BLEEDING, INFLAMMATION, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 25359847 ↗InjuryMay 28, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25316771 ↗InjuryMay 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, PAIN, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25214938 ↗InjuryApr 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24857256 ↗InjuryApr 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24857123 ↗InjuryApr 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PAIN, BLEEDING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24856042 ↗InjuryApr 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24855294 ↗InjuryMar 25, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED - ANOTHER SIZE OF IMPLANT WAS CHOSEN.
Patient problems: Inadequate Osseointegration
MAUDE report 24688302 ↗InjuryMar 25, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24688081 ↗InjuryMar 23, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24661551 ↗InjuryMar 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 24660139 ↗InjuryMar 20, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, TRAUMA / ACCIDENT, MOBILITY ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24648006 ↗InjuryMar 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, BONE RESORPTION, FISTULA.
Patient problems: Inadequate Osseointegration
MAUDE report 24617785 ↗InjuryMar 17, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24617092 ↗InjuryMar 16, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 24604763 ↗InjuryFeb 23, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, BLOOD COAGULATION DISORDER, SMOKER, PERIODONTAL DISEASE, COMPLICATION IN SITE PREPARATION, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24411999 ↗InjuryFeb 20, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, PAIN, SWELLING, INFLAMMATION, MOBILITY (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 24399540 ↗InjuryJan 30, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PSYCHOLOGICAL DISORDER, PAIN, INCREASED SENSITIVITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24220108 ↗InjuryJan 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, SMOKER.
Patient problems: Inadequate Osseointegration
MAUDE report 24219453 ↗InjuryJan 27, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, BRUXISM, BLEEDING, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24187784 ↗InjuryJan 26, 2026Failure 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 24177634 ↗
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