SPI ELEMENT INICELL 4.23.514Recalls & 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 Medical SPI Element Inicell is a bone implant. Most of the 306 reports describe the implant not bonding with the surrounding bone, and some mention poor initial stability, bleeding, inflammation, or pain. The reports include 306 injuries and no deaths, 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
- 307
- Deaths reported
- 0
- Injuries reported
- 307
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 307 adverse event reports that list this exact device (DI 07640156470307), received between Feb 16, 2018 and Sep 28, 2026 — classified as 307 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (246 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 Osseointegrate246
- Loss of Osseointegration60
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Inadequate Osseointegration221
- No Code Available85
- Implant Pain1
Recent adverse event reports
The 25 most recent of 307 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant wasn't completely covered with bone, immediate implantation ((b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50912002 ↗InjuryAug 27, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, smoker ((b)(6) and (b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50473262 ↗InjuryAug 27, 2026Failure to Osseointegrate
Primary stability not achieved, no thread tap used.
Patient problems: Inadequate Osseointegration
MAUDE report 50469182 ↗InjuryJul 14, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, BLEEDING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25810221 ↗InjuryJun 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, BISPHOSPHONATE TREATMENT, XEROSTOMIA, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25518771 ↗InjuryJun 8, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25425710 ↗InjuryMay 19, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 25214936 ↗InjuryMay 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, SMOKER, PAIN, SWELLING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25214909 ↗InjuryMay 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, INFECTION.
Patient problems: Inadequate Osseointegration
MAUDE report 25214835 ↗InjuryApr 21, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24936981 ↗InjuryMar 23, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, UNDERSIZED IMPLANT BED, INADEQUATE BONE QUALITY/QUANTITY
Patient problems: Inadequate Osseointegration
MAUDE report 24661472 ↗InjuryMar 5, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED - ANOTHER SIZE OF IMPLANT WAS CHOSEN.
Patient problems: Inadequate Osseointegration
MAUDE report 24516965 ↗InjuryFeb 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, DIABETES MELLITUS, IMMEDIATE IMPLANTATION, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, BLEEDING, INFLAMMATION (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24256747 ↗InjuryJan 27, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24187696 ↗InjuryJan 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24177007 ↗InjuryJan 22, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24142972 ↗InjuryJan 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, DIABETES MELLITUS, PAIN, INFLAMMATION ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24142909 ↗InjuryJan 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, DIABETES MELLITUS, SMOKER, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24129609 ↗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 24035712 ↗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 ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24035320 ↗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.
Patient problems: Inadequate Osseointegration
MAUDE report 24035252 ↗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 24002060 ↗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 ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24001754 ↗InjuryJan 8, 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 24001076 ↗InjuryNov 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23508795 ↗
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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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