SPI ELEMENT INICELL 4.23.522Recalls & 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 has 195 reports, all of them injuries, and no deaths. Nearly all describe the implant not bonding with the surrounding bone or losing that bond later, and some mention infection around the implant. 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
- 197
- Deaths reported
- 0
- Injuries reported
- 197
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 197 adverse event reports that list this exact device (DI 07640156470239), received between Jan 20, 2018 and Sep 15, 2026 — classified as 197 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (151 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 Osseointegrate151
- Loss of Osseointegration43
- Loosening of Implant Not Related to Bone-Ingrowth3
- Unstable1
Patient problems
- Inadequate Osseointegration153
- No Code Available43
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 197 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant was completely covered with bone, thread tap used, diabetes mellitus, smoker, mobility ((b)(6) and (b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50773470 ↗InjurySep 15, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant was completely covered with bone, thread tap used, diabetes mellitus, smoker, mobility ((b)(6) and (b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50773460 ↗InjuryAug 4, 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, bone resorption.
Patient problems: Inadequate Osseointegration
MAUDE report 50127521 ↗InjuryJun 8, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PERI-IMPLANTITIS, ABSCESS ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25425888 ↗InjuryJun 8, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PERI-IMPLANTITIS, ABSCESS ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25425885 ↗InjuryMay 26, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED - EPILEPSY.
Patient problems: Inadequate Osseointegration
MAUDE report 25275466 ↗InjuryMay 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, BRUXISM, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25214944 ↗InjuryMay 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN, BLEEDING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25214918 ↗InjuryApr 17, 2026Loosening of Implant Not Related to Bone-Ingrowth
IMPLANT REMOVAL DUE TO PATIENT'S WISH- IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24909726 ↗InjuryApr 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, IMMEDIATE IMPLANTATION, PERI-IMPLANTITIS, PAIN, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24855989 ↗InjuryMar 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, BRUXISM, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24604602 ↗InjuryMar 5, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 24516867 ↗InjuryFeb 27, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PERI-IMPLANTITIS.
Patient problems: Inadequate Osseointegration
MAUDE report 24466941 ↗InjuryFeb 5, 2026Failure to Osseointegrate
InjuryJan 27, 2026Loss of Osseointegration
InjuryJan 27, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS 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 24187736 ↗InjuryJan 27, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 24187652 ↗InjuryJan 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 24159689 ↗InjuryJan 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, ABSCESS, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 24158980 ↗InjuryJan 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 24144282 ↗InjuryJan 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, ABSCESS, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 24051219 ↗InjuryJan 12, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, ABSCESS, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 24035303 ↗InjuryJan 12, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, ABSCESS, BLEEDING (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24035285 ↗InjuryJan 8, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, ABSCESS, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 24001627 ↗InjuryJan 7, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, ABSCESS, MOBILITY (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 23987615 ↗
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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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