SPI ELEMENT INICELL 4.23.143Recalls & 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 implant is placed into bone, and all 510 reports are injury reports describing the bone not growing firmly onto the implant, with some implants later loosening. Several also mention pain, bleeding, infection, or an abscess, and some note that the bone was not prepared with a tap first. There are no deaths reported, and 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
- 509
- Deaths reported
- 0
- Injuries reported
- 509
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 509 adverse event reports that list this exact device (DI 07640156471137), received between Feb 16, 2018 and Sep 29, 2026 — classified as 509 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (390 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 Osseointegrate390
- Loss of Osseointegration112
- Loosening of Implant Not Related to Bone-Ingrowth4
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Patient-Device Incompatibility1
Patient problems
- Inadequate Osseointegration356
- No Code Available147
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
Recent adverse event reports
The 25 most recent of 509 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50930762 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, immediate implantation, pain, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50753969 ↗InjuryAug 26, 2026Failure to Osseointegrate
Primary stability not achieved, no thread tap used, blood coagulation disorder, inadequate bone quality/quantity.
Patient problems: Inadequate Osseointegration
MAUDE report 50450809 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, inflammation.
Patient problems: Inadequate Osseointegration
MAUDE report 50207819 ↗InjuryAug 5, 2026Failure to Osseointegrate
InjuryJul 14, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, INFECTION, PAIN, ABSCESS, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25812691 ↗InjuryJul 14, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, IMMEDIATE IMPLANTATION, INFECTION, PAIN, ABSCESS, MOBILITY (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25812668 ↗InjuryJul 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25811629 ↗InjuryJul 14, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25810011 ↗InjuryJul 8, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, PERI-IMPLANTITIS, INCREASED SENSITIVITY, ABSCESS
Patient problems: Inadequate Osseointegration
MAUDE report 25746951 ↗InjuryJul 8, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25744635 ↗InjuryJul 7, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERI-IMPLANTITIS, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 25729101 ↗InjuryJul 6, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25714633 ↗InjuryJun 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, INFECTION, PAIN, SWELLING, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 25543723 ↗InjuryJun 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25370839 ↗InjuryMay 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, BONE RESORPTION, INFECTION, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25274522 ↗InjuryMay 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 25214826 ↗InjuryApr 29, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, SMOKER, PAIN, ABSCESS, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25025471 ↗InjuryApr 22, 2026Failure to Osseointegrate
InjuryApr 21, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 24938000 ↗InjuryApr 10, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, DIABETES MELLITUS, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24843967 ↗InjuryMar 23, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION, UNDERSIZED IMPLANT BED.
Patient problems: Inadequate Osseointegration
MAUDE report 24660659 ↗InjuryMar 20, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24647888 ↗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, BONE RESORPTION, PERI-IMPLANTITIS.
Patient problems: Inadequate Osseointegration
MAUDE report 24603882 ↗InjuryMar 5, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24516850 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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