SPI CONTACT INICELL 4.23.636Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
All models of SPI CONTACT INICELL (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07640156470536), received between Dec 18, 2018 and Jun 12, 2026 — classified as 18 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (15 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 Osseointegrate15
- Loss of Osseointegration3
Patient problems
- Inadequate Osseointegration16
- No Code Available2
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, INFECTION (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25482342 ↗InjuryJun 12, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, INFECTION (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25482336 ↗InjuryJan 30, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, PERIODONTAL DISEASE, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24219935 ↗InjuryJan 23, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, ABSCESS, BLEEDING ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24158824 ↗InjuryJan 8, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, ABSCESS, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 24002074 ↗InjuryJan 7, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, ABSCESS, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 23988367 ↗InjuryNov 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, BONE RESORPTION, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23592610 ↗InjuryNov 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, PERIODONTAL DISEASE, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, MOBILITY - OVERLOADING.
Patient problems: Inadequate Osseointegration
MAUDE report 20331555 ↗InjuryJul 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 19652977 ↗InjuryJul 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 19644783 ↗InjuryApr 26, 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.
Patient problems: Inadequate Osseointegration
MAUDE report 19189620 ↗InjurySep 15, 2023Loss 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.
Patient problems: Inadequate Osseointegration
MAUDE report 17754432 ↗InjuryJan 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 14140830 ↗InjuryAug 24, 2021Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, COMPROMISED IMMUNE RESISTANCE, BONE RESORPTION.
Patient problems: Inadequate Osseointegration
MAUDE report 12358818 ↗InjuryDec 21, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 18, 2018Loss of Osseointegration; Loss of Osseointegration
PRIMARY STABILITY ACHIEVED. IMMEDIATE IMPLANTATION. PAIN WHEN TOUCHED. INCREASED SENSITIVITY, CONNECTIVE TISSUE.
Patient problems: No Code Available
MAUDE report 8173001 ↗
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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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