SPI CONTACT 4.13.213Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
All models of SPI CONTACT (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07640156471724), received between Apr 27, 2018 and May 18, 2023 — classified as 7 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (4 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.
Most reported problems
Device problems
- Loss of Osseointegration4
- Failure to Osseointegrate2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available4
- Inadequate Osseointegration3
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SWELLING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 16951903 ↗InjurySep 22, 2022Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, PERI-IMPLANTITIS, FISTULA, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 15469262 ↗InjuryFeb 9, 2021Loss 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, PERI-IMPLANTITIS, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 11299675 ↗InjurySep 25, 2019Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, RADIATION TX-HEAD / NECK AREA, ILLNESS REQUIRING STEROIDS.
Patient problems: No Code Available
MAUDE report 9115479 ↗InjuryDec 15, 2018Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 31, 2018Adverse Event Without Identified Device or Use Problem
PRIMARY STABILITY AND OSSEOINTEGRATION ACHIEVED. PAIN.
Patient problems: No Code Available
MAUDE report 7556041 ↗InjuryApr 27, 2018Loss of Osseointegration; Loss of Osseointegration
PAIN, ABSCESS, LOSS OF IMPLANT. SUSPECTED VERTICAL BONE LOSS.
Patient problems: No Code Available
MAUDE report 7468588 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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