SPI ELEMENT INICELL 4.23.724Recalls & 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
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07640156470185), received between Apr 27, 2018 and Apr 8, 2026 — classified as 19 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (17 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 Osseointegrate17
- Loss of Osseointegration2
Patient problems
- Inadequate Osseointegration15
- No Code Available4
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24813046 ↗InjuryMay 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED - ANOTHER TYPE OF IMPLANT WAS CHOSEN.
Patient problems: Inadequate Osseointegration
MAUDE report 22000526 ↗InjuryFeb 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION. (B)(6) ARE THE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 18720684 ↗InjuryJun 30, 2023Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 17235480 ↗InjuryMay 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 17, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, BLOOD COAGULATION DISORDER, BIOMECHANICAL OVERLOAD ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 15238838 ↗InjuryAug 17, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, BLOOD COAGULATION DISORDER, BIOMECHANICAL OVERLOAD ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 15238835 ↗InjuryJan 26, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, SWELLING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 13354382 ↗InjuryDec 7, 2021Failure to Osseointegrate; Failure 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 12948271 ↗InjuryNov 23, 2021Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 12859025 ↗InjuryJun 19, 2021Failure 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 ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 12029930 ↗InjuryJun 19, 2021Failure 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 ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 12029929 ↗InjuryJun 19, 2021Failure 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 ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 12029927 ↗InjuryMar 2, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 11398062 ↗InjuryMar 2, 2021Failure 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, PERIODONTAL DISEASE, DISEASED MUCOUS MEMBRANE, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, COMPLICATION IN SITE PREPARATION, PERHAPS BIOMECHANICAL OVERLOAD, PERHAPS INADEQUATE BONE QUALITY/QUANTITY, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 11397504 ↗InjurySep 28, 2020Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY. ANOTHER IMPLANT WITH PF 4.5 HAS BEEN PLACED.
Patient problems: No Code Available
MAUDE report 10592227 ↗InjuryApr 9, 2019Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION - NO THREAD TAP USED, IMPLANT WAS COMPLETELY COVERED BY BONE, INFECTION, PAIN, SWELLING.
Patient problems: No Code Available
MAUDE report 8495565 ↗InjuryNov 24, 2018Loss of Osseointegration; Loss of Osseointegration
InjuryApr 27, 2018Failure to Osseointegrate; Failure to Osseointegrate
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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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