SPI®NEVO RC INICELL®, healing cap incl., PF 4.5, endosseous Ø 4.2 mm, L 11.0 mm 4.23.034Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Thommen Medical SPI NEVO RC INICELL dental implant healing cap appears in 23 adverse event reports, all classified as injuries with no deaths. The reports consistently describe the implant failing to bond with the jawbone (osseointegration), often mentioning implant mobility, pain, swelling, infection or peri-implantitis; one report mentions an insertion aid spinning out of control inside the implant. No recalls name this device. Report volume has been steady, with 11 reports in the last 12 months and 11 in the prior 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
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07640182643492), received between Sep 5, 2024 and Aug 27, 2026 — classified as 23 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 Osseointegration2
Patient problems
- Inadequate Osseointegration23
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, peri-implantitis.
Patient problems: Inadequate Osseointegration
MAUDE report 50471640 ↗InjuryAug 5, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, immediate implantation, pain, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50141395 ↗InjuryMay 26, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED - INSERTION AID SPUN OUT OF CONTROL INSIDE THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 25275029 ↗InjuryMay 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERI-IMPLANTITIS, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25214781 ↗InjuryApr 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, ABSCESS, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24857161 ↗InjuryMar 5, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, THREAD TAP USED, IMMEDIATE IMPLANTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24516819 ↗InjuryMar 4, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24510680 ↗InjuryJan 21, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24130476 ↗InjuryDec 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, PERIODONTAL DISEASE, COMPLICATION IN SITE PREPARATION (B)(6) ARE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 23905003 ↗InjuryNov 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23614660 ↗InjuryNov 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, INFECTION.
Patient problems: Inadequate Osseointegration
MAUDE report 23521409 ↗InjuryOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMMEDIATE IMPLANTATION, INFECTION, BLEEDING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23298783 ↗InjuryAug 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, MOBILITY: ANOTHER SIZE OF IMPLANT WAS CHOSEN.
Patient problems: Inadequate Osseointegration
MAUDE report 22902349 ↗InjuryAug 21, 2025Failure to Osseointegrate; Failure 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 22858376 ↗InjuryAug 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 22747914 ↗InjuryJul 21, 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, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22554550 ↗InjuryJun 16, 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, IMMEDIATE IMPLANTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22209639 ↗InjuryJun 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PSYCHOLOGICAL DISORDER, COMPLICATION IN SITE PREPARATION, IMMEDIATE IMPLANTATION, INADEQUATE BONE QUALITY/QUANTITY, BONE RESORPTION, INCREASED SENSITIVITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22191952 ↗InjuryMay 13, 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, BLEEDING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22010885 ↗InjuryMar 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, BLOOD COAGULATION DISORDER, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 21686737 ↗InjuryFeb 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED ON (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 21457791 ↗InjuryDec 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20852444 ↗InjurySep 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMMEDIATE IMPLANTATION ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 20146259 ↗
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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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