SPI®NEVO RC INICELL®, healing cap incl., PF 4.5, endosseous Ø 4.2 mm, L 8.0 mm 4.23.032Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Thommen SPI Nevo dental implant is placed in the jaw to support dental work. Reports mostly describe implants not bonding with the bone and becoming loose, sometimes with pain, swelling or bleeding. There are 24 reports that mention 24 injuries and no deaths, with 17 reports in the last 12 months compared with 7 in the prior 12 months. 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
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07640182643478), received between Apr 24, 2025 and Sep 28, 2026 — classified as 24 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (21 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 Osseointegrate21
- Loss of Osseointegration3
Patient problems
- Inadequate Osseointegration24
Recent adverse event reports
The 24 most recent of 24 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, diabetes mellitus, smoker, peri-implantitis, swelling, abscess, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50911803 ↗InjuryAug 4, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, preceding/simultaneous bone augmentation, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50127480 ↗InjuryJul 14, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION ((B)(6) AND (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25811952 ↗InjuryJul 14, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, PAIN, SWELLING.
Patient problems: Inadequate Osseointegration
MAUDE report 25810272 ↗InjuryJul 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN, SWELLING, BLEEDING
Patient problems: Inadequate Osseointegration
MAUDE report 25795404 ↗InjuryJul 9, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PERI-IMPLANTITIS
Patient problems: Inadequate Osseointegration
MAUDE report 25761364 ↗InjuryJun 18, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25544825 ↗InjuryJun 16, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25519900 ↗InjuryMay 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, BISPHOSPHONATE TREATMENT, BLEEDING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25214782 ↗InjuryApr 22, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION.
Patient problems: Inadequate Osseointegration
MAUDE report 24951994 ↗InjuryApr 3, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, SMOKER, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24774463 ↗InjuryMar 4, 2026Loss of Osseointegration
InjuryMar 2, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24480579 ↗InjuryJan 22, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24142076 ↗InjuryNov 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION, INADEQUATE BONE QUALITY/QUANTITY, PAIN, SWELLING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23665024 ↗InjuryNov 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23591143 ↗InjuryNov 5, 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, PERIODONTAL DISEASE, PERI-IMPLANTITIS, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23475528 ↗InjuryOct 31, 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, PSYCHOLOGICAL DISORDER, PAIN, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23435504 ↗InjuryAug 14, 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, SMOKER, PAIN, BLEEDING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22802086 ↗InjuryAug 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, BIOMECHANICAL OVERLOAD.
Patient problems: Inadequate Osseointegration
MAUDE report 22792051 ↗InjuryJul 10, 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, SMOKER.
Patient problems: Inadequate Osseointegration
MAUDE report 22466566 ↗InjuryJul 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION, IMMEDIATE IMPLANTATION - ANOTHER SIZE OF IMPLANT WAS CHOSEN.
Patient problems: Inadequate Osseointegration
MAUDE report 22211101 ↗InjuryApr 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 21900296 ↗
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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