SPI ELEMENT INICELL 4.23.134Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
All models of SPI ELEMENT INICELL (67)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Thommen SPI Element Inicell implant is placed into the bone. Its 484 adverse event reports mostly describe the implant failing to bond with the surrounding bone, with some also mentioning infection, pain, and implant mobility. There are 484 injuries and no deaths. 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
- 482
- Deaths reported
- 0
- Injuries reported
- 482
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 482 adverse event reports that list this exact device (DI 07640156471182), received between Jan 19, 2018 and Sep 30, 2026 — classified as 482 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (388 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 Osseointegrate388
- Loss of Osseointegration84
- Break6
- Loosening of Implant Not Related to Bone-Ingrowth3
- Patient-Device Incompatibility1
Patient problems
- Inadequate Osseointegration331
- No Code Available144
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 482 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, immediate implantation, pain, inflammation.
Patient problems: Inadequate Osseointegration
MAUDE report 50943166 ↗InjuryAug 5, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant was completely covered with bone, immediate implantation, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50140534 ↗InjuryJul 14, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PERI-IMPLANTITIS, INFECTION, INFLAMMATION (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25811656 ↗InjuryJul 8, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMMEDIATE IMPLANTATION, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25746659 ↗InjuryJun 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED 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 25593536 ↗InjuryJun 2, 2026Loss of Osseointegration
InjuryMay 26, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, INFLAMMATION ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25276487 ↗InjuryMay 26, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, INFLAMMATION ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25276467 ↗InjuryMay 26, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, INADEQUATE BONE QUALITY/QUANTITY - ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25276090 ↗InjuryApr 29, 2026Loss of Osseointegration
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25030454 ↗InjuryApr 27, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN, ABSCESS, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24997363 ↗InjuryApr 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 24855026 ↗InjuryApr 8, 2026Failure to Osseointegrate
InjuryMar 25, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24686092 ↗InjuryMar 25, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 24685399 ↗InjuryMar 5, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24517444 ↗InjuryMar 5, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, COMPLICATION IN SITE PREPARATION, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24516682 ↗InjuryMar 4, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PERI-IMPLANTITIS, INFECTION, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 24510545 ↗InjuryMar 2, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, INADEQUATE BONE QUALITY/QUANTITY, PRECEDING/SIMULTANEOUS BONE AUGMENTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24482201 ↗InjuryFeb 4, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24257177 ↗InjuryFeb 3, 2026Loss 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, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24245511 ↗InjuryJan 30, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, BLOOD COAGULATION DISORDER, PERIODONTAL DISEASE, COMPLICATION IN SITE PREPARATION, INADEQUATE BONE QUALITY/QUANTITY, BONE RESORPTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24220076 ↗InjuryJan 23, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 24161025 ↗InjuryJan 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24142575 ↗InjuryJan 8, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, DISEASED MUCOUS MEMBRANE, INFECTION, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24000823 ↗
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 16, 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