SPI CONTACT 4.13.220Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
All models of SPI CONTACT (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07640156471700), received between Jun 23, 2018 and Apr 13, 2026 — classified as 14 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (11 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate11
- Break2
- Loss of Osseointegration1
Patient problems
- No Code Available8
- Inadequate Osseointegration4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERIODONTAL DISEASE, PERI-IMPLANTITIS, MOBILITY (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24854840 ↗InjuryJan 31, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 16270368 ↗InjurySep 29, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE.
Patient problems: Inadequate Osseointegration
MAUDE report 15508259 ↗InjurySep 14, 2022Break; Break
IMPLANT FRACTURE, IMPLANT ACHIEVED OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, MOBILITY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15417480 ↗InjuryJul 28, 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, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 15120052 ↗InjuryNov 12, 2021Break; Break
IMPLANT FRACTURE, IMPLANT ACHIEVED OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, PAIN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12801722 ↗InjuryFeb 5, 2020Failure 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 ((B)(6) ARE SAME PATIENT).
Patient problems: No Code Available
MAUDE report 9669611 ↗InjurySep 10, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, POOR HYGIENE.
Patient problems: No Code Available
MAUDE report 8978624 ↗InjuryMar 25, 2019Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION - DRUG OR ALCOHOL ABUSE, INADEQUATE BONE QUALITY/QUANTITY, FISTULA.
Patient problems: No Code Available
MAUDE report 8447919 ↗InjuryMar 25, 2019Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION - DIABETES MELLITUS, DRUG OR ALCOHOL ABUSE, SMOKER, PERIODONTAL DISEASE, INADEQUATE BONE QUALITY/QUANTITY, PERI-IMPLANTITIS, BLEEDING.
Patient problems: No Code Available
MAUDE report 8447918 ↗InjuryMar 20, 2019Failure to Osseointegrate; Failure to Osseointegrate
NO THREAD TAP USED, PRIMARY STABILITY WAS ACHIEVED, IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED BY BONE, INCREASED SENSITIVITY, INFLAMMATION.
Patient problems: No Code Available
MAUDE report 8435889 ↗InjuryMar 20, 2019Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 20, 2019Failure to Osseointegrate; Failure to Osseointegrate
NO THREAD TAP USED, PRIMARY STABILITY WAS ACHIEVED, IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED BY BONE, INFECTION, PAIN, INFLAMMATION, MOBILITY, AFTER 15 DAYS PATIENT CLAIMED ABOUT PAIN, IMPLANT EXTRACTION.
Patient problems: No Code Available
MAUDE report 8435877 ↗InjuryJun 23, 2018Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION ACHIEVED, BONE RESORPTION.
Patient problems: No Code Available
MAUDE report 7632377 ↗
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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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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