SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 8.0 mm 4.23.022Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a SPI®NEVO RC INICELL® endosseous dental implant by Thomomen Medical AG. The 27 reports describe the implant failing to fuse with the surrounding bone, so it loses stability, becomes mobile, and sometimes falls out or gets covered over by bone; reports also mention infection and bone resorption. All 27 reports are injuries, with no deaths. No recalls name this device. Reports rose from 5 in the prior 12 months to 22 in the last 12 months.
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
- 26
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07640182643416), received between Apr 23, 2025 and Sep 28, 2026 — classified as 26 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (22 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 Osseointegrate22
- Loss of Osseointegration4
Patient problems
- Inadequate Osseointegration26
Recent adverse event reports
The 25 most recent of 26 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, no thread tap used, smoker, immediate implantation, pain, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50911781 ↗InjuryAug 11, 2026Failure to Osseointegrate
Primary stability not achieved, implant was completely covered with bone, no thread tap used, inadequate bone quality/quantity.
Patient problems: Inadequate Osseointegration
MAUDE report 50207710 ↗InjuryAug 11, 2026Failure to Osseointegrate
Primary stability not achieved, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50207319 ↗InjuryJul 13, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 25794691 ↗InjuryJul 13, 2026Failure to Osseointegrate
InjuryJul 13, 2026Loss of Osseointegration
InjuryMay 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, BONE RESORPTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25214808 ↗InjuryApr 28, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25013466 ↗InjuryApr 28, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SWELLING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25013449 ↗InjuryApr 28, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25013360 ↗InjuryApr 13, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, BLOOD COAGULATION DISORDER, COMPLICATION IN SITE PREPARATION, MOBILITY - ANOTHER SIZE OF IMPLANT WAS CHOSEN.
Patient problems: Inadequate Osseointegration
MAUDE report 24857349 ↗InjuryApr 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24856066 ↗InjuryApr 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24855650 ↗InjuryMar 5, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER.
Patient problems: Inadequate Osseointegration
MAUDE report 24516772 ↗InjuryMar 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24504601 ↗InjuryFeb 27, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, BONE RESORPTION.
Patient problems: Inadequate Osseointegration
MAUDE report 24468308 ↗InjuryFeb 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, INFECTION (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24388670 ↗InjuryJan 5, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, DIABETES MELLITUS.
Patient problems: Inadequate Osseointegration
MAUDE report 23956969 ↗InjuryNov 24, 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, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23631275 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, BONE RESORPTION.
Patient problems: Inadequate Osseointegration
MAUDE report 23473932 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, INADEQUATE BONE QUALITY/QUANTITY (B)(6), ARE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 23473832 ↗InjuryOct 28, 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, DRUG OR ALCOHOL ABUSE, INADEQUATE BONE QUALITY/QUANTITY, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23401552 ↗InjuryAug 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 22882798 ↗InjuryAug 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 22848177 ↗InjuryAug 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, SMOKER, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22780259 ↗
Other Implant, Endosseous, Root-Form devices
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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