SPI CONTACT 4.13.211Recalls & 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
Quick summary
This Thommen Medical SPI dental implant is a root-form screw implant placed into the jawbone. The 29 reports mostly describe the implant failing to fuse with the surrounding bone, or losing that fusion later, so it does not stay stable and can become mobile. All 29 reports involve injuries, with no deaths mentioned. 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 07640156471748), received between May 31, 2018 and Mar 26, 2024 — classified as 29 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (22 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 Osseointegrate22
- Loss of Osseointegration7
Patient problems
- Inadequate Osseointegration19
- No Code Available10
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryMar 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, SMOKER, PERIODONTAL DISEASE, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 18976961 ↗InjuryFeb 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, SMOKER, PERIODONTAL DISEASE, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 18795350 ↗InjuryFeb 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, PERIODONTAL DISEASE, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 18795277 ↗InjuryFeb 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, SMOKER, PERIODONTAL DISEASE, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 18795198 ↗InjuryNov 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE.
Patient problems: Inadequate Osseointegration
MAUDE report 18128666 ↗InjuryJun 20, 2023Failure 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.
Patient problems: Inadequate Osseointegration
MAUDE report 17160874 ↗InjuryJun 20, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 17160200 ↗InjuryMay 4, 2023Failure 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 16868162 ↗InjuryMay 4, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION, OVERHEATING OF BONE ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 16866928 ↗InjuryMay 4, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, DIABETES MELLITUS, SMOKER, PERIODONTAL DISEASE, PAIN, MOBILITY (2023_0709, 2023_0710 AND 2023_0711 ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 16866590 ↗InjuryMay 4, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 16866575 ↗InjuryMay 4, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, SMOKER, PERIODONTAL DISEASE, COMPLICATION IN SITE PREPARATION, INADEQUATE BONE QUALITY/QUANTITY, INFECTION, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 16866317 ↗InjuryApr 25, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, INFECTION, SWELLING, MOBILITY (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 16807452 ↗InjurySep 22, 2022Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, BIOMECHANICAL OVERLOAD.
Patient problems: Inadequate Osseointegration
MAUDE report 15469071 ↗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 15119366 ↗InjuryFeb 23, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 13582825 ↗InjuryFeb 7, 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 13469088 ↗InjurySep 11, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 15, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED. SAME PATIENT AS (B)(6).
Patient problems: Inadequate Osseointegration
MAUDE report 11327156 ↗InjuryJul 13, 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, MOBILITY.
Patient problems: No Code Available
MAUDE report 10263543 ↗InjuryMar 25, 2019Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION - PRIMARY STABILITY WAS ACHIEVED, THREAD TAP USED, SMOKER, DIABETES, PERIODONTAL DISEASE AT THE TIME OF SURGERY, BONE RESORPTION, PERIIMPLANTITIS, SWELLING, ABSCESS, BLEEDING, INFLAMMATION ((B)(6) ARE SAME PATIENT).
Patient problems: No Code Available
MAUDE report 8447887 ↗InjuryMar 25, 2019Loss of Osseointegration; Loss of Osseointegration
SMOKER, PERIODONTAL DISEASE, THREAD TAP USED, PRIMARY STABILITY WAS ACHIEVED, IMPLANT ACHIEVED OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED BY BONE, BRUXISM, BONE RESORPTION, PERI-IMPLANTITIS, SWELLING, FISTULA, ABSCESS ((B)(6) ARE SAME PATIENT).
Patient problems: No Code Available
MAUDE report 8447881 ↗InjuryMar 25, 2019Loss of Osseointegration; Loss of Osseointegration
SMOKER, PERIODONTAL DISEASE, THREAD TAP USED, PRIMARY STABILITY WAS ACHIEVED, IMPLANT ACHIEVED OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED BY BONE, BRUXISM, BONE RESORPTION, PERI-IMPLANTITIS, SWELLING, FISTULA, ABSCESS (2019_0473, 0474 AND 0475 ARE SAME PATIENT).
Patient problems: No Code Available
MAUDE report 8447877 ↗InjuryMar 25, 2019Loss of Osseointegration; Loss of Osseointegration
SMOKER, PERIODONTAL DISEASE, THREAD TAP USED, PRIMARY STABILITY WAS ACHIEVED, IMPLANT ACHIEVED OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED BY BONE, BRUXISM, BONE RESORPTION, PERI-IMPLANTITIS, SWELLING, FISTULA, ABSCESS ((B)(6) ARE SAME PATIENT).
Patient problems: No Code Available
MAUDE report 8447874 ↗InjuryMar 20, 2019Failure to Osseointegrate; Failure to Osseointegrate
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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