SPI CONTACT 4.13.212Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640156471731), received between Dec 8, 2018 and Feb 6, 2022 — classified as 5 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 Osseointegrate1
Patient problems
- No Code Available4
- Inadequate Osseointegration1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2022Failure to Osseointegrate; Failure 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.
Patient problems: Inadequate Osseointegration
MAUDE report 13467166 ↗InjurySep 3, 2019Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INADEQUATE BONE QUALITY/QUANTITY, INFECTION, SMOKER ((B)(6) ARE SAME PATIENT).
Patient problems: No Code Available
MAUDE report 8954633 ↗InjuryJun 28, 2019Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERIODONTAL DISEASE AT TIME OF SURGERY, NO THREAD TAP USED, PRIMARY STABILITY WAS ACHIEVED, IMPLANT ACHIEVED OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED BY BONE, BIOMECHANICAL OVERLOAD ON LOCATOR POSSIBLE, PERI-IMPLANTITIS, SWELLING, ABSCESS, MOBILITY.
Patient problems: No Code Available
MAUDE report 8743042 ↗InjuryMar 29, 2019Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, NO THREAD TAP USED, PRIMARY STABILITY WAS ACHIEVED, IMPLANT ACHIEVED OSSEOINTEGRATION, IMPLANT WASN'T COMPLETELY COVERED BY BONE, PAIN, SWELLING.
Patient problems: No Code Available
MAUDE report 8463222 ↗InjuryDec 8, 2018Loss of Osseointegration; Loss of Osseointegration
PRIMARY STABILITY AND OSSEOINTEGRATION ACHIEVED. AT THE TIME OF SURGERY PERIODONTITIS. BONE RESORPTION, PERI-IMPLANTITIS. LOSS OF IMPLANT.
Patient problems: No Code Available
MAUDE report 8144781 ↗
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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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