SPI ELEMENT 4.13.911Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
Quick summary
This Thommen SPI Element dental implant, a screw placed in the jawbone to hold a replacement tooth, has 115 adverse event reports on file. Most describe the implant failing to fuse with the jawbone or losing that bond, and some describe peri-implantitis. The reports include no deaths and 115 injuries, and the number of reports fell from 5 to 0 over the last 12 months. 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
- 115
- Deaths reported
- 0
- Injuries reported
- 115
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 07640156471489), received between Feb 1, 2018 and Oct 15, 2025 — classified as 115 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (76 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate76
- Loss of Osseointegration33
- Break5
- Loose or Intermittent Connection1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Unstable1
Patient problems
- Inadequate Osseointegration72
- No Code Available40
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Implant Pain1
Recent adverse event reports
The 25 most recent of 115 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERI-IMPLANTITIS ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 23299246 ↗InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERI-IMPLANTITIS (B)(6) ARE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 23298893 ↗InjuryJan 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERI-IMPLANTITIS.
Patient problems: Inadequate Osseointegration
MAUDE report 21196165 ↗InjuryNov 19, 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, SMOKER, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20721271 ↗InjuryNov 6, 2024Loss 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, SWELLING.
Patient problems: Inadequate Osseointegration
MAUDE report 20619398 ↗InjuryOct 28, 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, SMOKER, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20544222 ↗InjuryOct 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERIODONTAL DISEASE.
Patient problems: Inadequate Osseointegration
MAUDE report 20520187 ↗InjuryOct 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION, INFECTION.
Patient problems: Inadequate Osseointegration
MAUDE report 20520178 ↗InjuryOct 23, 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, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20512819 ↗InjuryOct 23, 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 20512788 ↗InjuryAug 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19917850 ↗InjuryAug 4, 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, INFLAMMATION, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 19902535 ↗InjuryAug 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19901647 ↗InjuryAug 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19901646 ↗InjuryAug 3, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19901635 ↗InjuryAug 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19901400 ↗InjuryAug 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19901393 ↗InjuryJul 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19787984 ↗InjuryJul 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, SMOKER, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19769352 ↗InjuryJul 17, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, MOBILITY (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 19760988 ↗InjuryJul 17, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 19760979 ↗InjuryJul 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19760921 ↗InjuryJul 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 19749878 ↗InjuryJul 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19748034 ↗InjuryJul 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19740414 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.