SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 9.5 mm 4.23.023Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Thommen Medical SPI®NEVO RC healing cap, a small endosseous dental implant used to support healing of the jawbone. The 47 reports mostly describe the implant failing to fuse with the surrounding bone, leaving it loose or mobile, with some patients reporting pain and inflammation. All 47 reports are injuries, with no deaths. 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
- 51
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 07640182643423), received between May 24, 2024 and Sep 28, 2026 — classified as 51 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (48 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 Osseointegrate48
- Loss of Osseointegration2
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Inadequate Osseointegration51
Recent adverse event reports
The 25 most recent of 51 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 was completely covered with bone, no thread tap used, bone resorption, peri-implantitis, infection, inflammation, mobility ((b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50911739 ↗InjurySep 28, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, bone resorption, peri-implantitis, infection, inflammation, mobility ((b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50911734 ↗InjurySep 28, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, immediate implantation, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50910906 ↗InjurySep 15, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, implant wasn't completely covered with bone, no thread tap used, pain.
Patient problems: Inadequate Osseointegration
MAUDE report 50773122 ↗InjuryAug 27, 2026Failure to Osseointegrate
Primary stability not achieved, implant wasn't completely covered with bone.
Patient problems: Inadequate Osseointegration
MAUDE report 50469298 ↗InjuryAug 27, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50469124 ↗InjuryAug 27, 2026Failure to Osseointegrate
Primary stability not achieved ((b)(6) and (b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50469040 ↗InjuryAug 27, 2026Failure to Osseointegrate
InjuryAug 27, 2026Failure to Osseointegrate
InjuryAug 11, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant was completely covered with bone, smoker, pain, inflammation, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50208217 ↗InjuryJul 10, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED
Patient problems: Inadequate Osseointegration
MAUDE report 25774889 ↗InjuryJul 6, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, SMOKER.
Patient problems: Inadequate Osseointegration
MAUDE report 25713736 ↗InjuryMay 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFECTION, PAIN, SWELLING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25214807 ↗InjuryApr 29, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER, PERI-IMPLANTITIS, PAIN, NUMBNESS, INFLAMMATION, MOBILITY. (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 25026694 ↗InjuryApr 29, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, COMPLICATION IN SITE PREPARATION - ANOTHER SIZE OF IMPLANT WAS CHOSEN.
Patient problems: Inadequate Osseointegration
MAUDE report 25024671 ↗InjuryApr 28, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25013520 ↗InjuryMar 26, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24697499 ↗InjuryMar 5, 2026Failure to Osseointegrate
InjuryMar 5, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, SMOKER.
Patient problems: Inadequate Osseointegration
MAUDE report 24516657 ↗InjuryFeb 27, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, BONE RESORPTION.
Patient problems: Inadequate Osseointegration
MAUDE report 24468516 ↗InjuryFeb 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERI-IMPLANTITIS, PAIN, SWELLING, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24412451 ↗InjuryFeb 4, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, UNDERSIZED IMPLANT BED.
Patient problems: Inadequate Osseointegration
MAUDE report 24257283 ↗InjuryJan 22, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, IMMEDIATE IMPLANTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24142768 ↗InjuryJan 21, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, DIABETES MELLITUS, SMOKER, COMPLICATION IN SITE PREPARATION, IMMEDIATE IMPLANTATION, UNDERSIZED IMPLANT BED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24130509 ↗InjuryDec 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 23921254 ↗
Other Implant, Endosseous, Root-Form devices
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- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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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