SPI ELEMENT INICELL 4.23.125Recalls & 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 Medical SPI Element Inicell is a bone implant. Most of the 305 reports describe the implant not bonding with the surrounding bone, and some mention poor initial stability, looseness, bleeding, or inflammation. The reports include 305 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
- 304
- Deaths reported
- 0
- Injuries reported
- 304
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 304 adverse event reports that list this exact device (DI 07640156471229), received between Jan 26, 2018 and Sep 14, 2026 — classified as 304 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (245 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 Osseointegrate245
- Loss of Osseointegration58
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Inadequate Osseointegration189
- No Code Available114
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 304 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration, implant was completely covered with bone, no thread tap used, smoker, pain, increased sensitivity.
Patient problems: Inadequate Osseointegration
MAUDE report 50750338 ↗InjuryAug 27, 2026Failure to Osseointegrate
InjuryJun 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PERI-IMPLANTITIS, BLEEDING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25590970 ↗InjuryJun 15, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, COMPLICATION IN SITE PREPARATION, BLEEDING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25503742 ↗InjuryJun 10, 2026Loss of Osseointegration
InjuryMay 27, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, TRAUMA / ACCIDENT, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25299275 ↗InjuryApr 28, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, MOBILITY (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25016428 ↗InjuryApr 28, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, MOBILITY (B)(6) ARE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 25016199 ↗InjuryApr 10, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, PERIODONTAL DISEASE, LOCAL INFECTION/SUBACUTE CHRONIC OSTEITIS, IMMEDIATE IMPLANTATION, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24838871 ↗InjuryMar 15, 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, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24601585 ↗InjuryFeb 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, MOBILITY - FIBROINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24389692 ↗InjuryJan 19, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY, PERI-IMPLANTITIS, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24107259 ↗InjuryDec 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED - ANOTHER SIZE OF IMPLANT WAS CHOSEN (B)(6) ARE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 23904685 ↗InjuryNov 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMMEDIATE IMPLANTATION, INFLAMMATION ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 23614346 ↗InjuryNov 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 23602935 ↗InjuryNov 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERIODONTAL DISEASE, PAIN, SWELLING, BLEEDING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23494764 ↗InjuryOct 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, BONE RESORPTION ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 23388785 ↗InjuryOct 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFECTION, PAIN, FISTULA, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23388715 ↗InjuryOct 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMMEDIATE IMPLANTATION, SWELLING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23357597 ↗InjuryAug 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22768979 ↗InjuryJul 24, 2025Failure to Osseointegrate; Failure 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.
Patient problems: Inadequate Osseointegration
MAUDE report 22585597 ↗InjuryJul 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERIODONTAL DISEASE, PERI-IMPLANTITIS ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 22540377 ↗InjuryJul 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERIODONTAL DISEASE, PERI-IMPLANTITIS (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 22540376 ↗InjuryJun 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PERI-IMPLANTITIS, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22357239 ↗InjuryJun 26, 2025Loss of Osseointegration; Loss 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 22334702 ↗
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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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