SPI ELEMENT INICELL 4.23.141Recalls & 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 implant is a root-form implant placed in bone. Most reports describe the implant failing to fuse with the bone or later losing its hold on it, and some mention infection, pain and loose implants. There are 258 reports, with no deaths and 258 injuries. 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
- 257
- Deaths reported
- 0
- Injuries reported
- 257
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 257 adverse event reports that list this exact device (DI 07640156470864), received between Jan 26, 2018 and Sep 28, 2026 — classified as 257 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (181 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 Osseointegrate181
- Loss of Osseointegration76
Patient problems
- Inadequate Osseointegration190
- No Code Available67
Recent adverse event reports
The 25 most recent of 257 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, increased sensitivity, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50911700 ↗InjuryAug 11, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration.
Patient problems: Inadequate Osseointegration
MAUDE report 50207922 ↗InjuryJul 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFECTION, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25809891 ↗InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, OVERHEATING OF BONE (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 25728890 ↗InjuryJun 10, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, ILLNESS REQUIRING STEROIDS, DRUG OR ALCOHOL ABUSE, SMOKER, PERIODONTAL DISEASE, UNDERSIZED IMPLANT BED.
Patient problems: Inadequate Osseointegration
MAUDE report 25455422 ↗InjuryApr 28, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMMEDIATE IMPLANTATION, BONE RESORPTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25014153 ↗InjuryApr 27, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INCREASED SENSITIVITY, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24996924 ↗InjuryApr 13, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE.
Patient problems: Inadequate Osseointegration
MAUDE report 24855903 ↗InjuryApr 13, 2026Failure to Osseointegrate
InjuryMar 5, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24516328 ↗InjuryFeb 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERIODONTAL DISEASE, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24388914 ↗InjuryJan 13, 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 24051111 ↗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, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 23988294 ↗InjuryNov 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23669831 ↗InjuryNov 27, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, INFECTION, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 23663852 ↗InjuryNov 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 23615839 ↗InjuryNov 17, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 5, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 23093459 ↗InjurySep 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23074530 ↗InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, DIABETES MELLITUS, SINUS PERFORATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23003195 ↗InjuryAug 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22921129 ↗InjuryAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 22892623 ↗InjuryAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED. NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 22892235 ↗InjuryAug 25, 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, INADEQUATE BONE QUALITY/QUANTITY, PERI-IMPLANTITIS, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22882402 ↗
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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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