SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 11.0 mm 4.23.014Recalls & 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 SPIRINEVO RC healing cap, a small screw-shaped implant used to hold a tooth implant site closed while the bone heals underneath. The 29 reports mostly describe the implant not fusing with the surrounding bone, so it stays loose or comes out; some mention swelling, fistulas or abscesses at the site. All 29 reports involve injuries and none report a death. 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
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 07640182643379), received between Oct 21, 2024 and Sep 28, 2026 — classified as 29 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (28 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 Osseointegrate28
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration29
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Primary stability not achieved, implant wasn't completely covered with bone, no thread tap used.
Patient problems: Inadequate Osseointegration
MAUDE report 50911112 ↗InjuryAug 28, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50492887 ↗InjuryJul 7, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25733013 ↗InjuryJun 16, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25518871 ↗InjuryMay 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, SWELLING, FISTULA, ABSCESS.
Patient problems: Inadequate Osseointegration
MAUDE report 25214813 ↗InjuryApr 29, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25026509 ↗InjuryApr 29, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25025720 ↗InjuryApr 29, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, MOBILITY (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25025653 ↗InjuryApr 29, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25025639 ↗InjuryMar 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, BONE RESORPTION.
Patient problems: Inadequate Osseointegration
MAUDE report 24601574 ↗InjuryMar 4, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24504687 ↗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, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 24388715 ↗InjuryNov 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, NO THREAD TAP USED, SWELLING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23669976 ↗InjuryNov 19, 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 23591436 ↗InjuryNov 19, 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, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, INFECTION, PAIN, BLEEDING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23591175 ↗InjuryOct 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED - ANOTHER SIZE OF IMPLANT WAS CHOSEN.
Patient problems: Inadequate Osseointegration
MAUDE report 23414907 ↗InjuryOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 23300133 ↗InjuryAug 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 22881895 ↗InjuryAug 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, THREAD TAP USED, INFECTION, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22780482 ↗InjuryJun 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PSYCHOLOGICAL DISORDER, SMOKER, PERIODONTAL DISEASE, COMPLICATION IN SITE PREPARATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22183540 ↗InjuryMay 13, 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, BIOMECHANICAL OVERLOAD, PAIN, INCREASED SENSITIVITY, MOBILITY - IMMEDIATE LOADING.
Patient problems: Inadequate Osseointegration
MAUDE report 22011208 ↗InjuryApr 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMMEDIATE IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 21890035 ↗InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SWELLING, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 21705940 ↗InjuryMar 4, 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 21513632 ↗InjuryMar 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 21512991 ↗
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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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