SPI ELEMENT 4.13.942Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Thommen SPI Element dental implant has 106 reports, no deaths and 106 injuries. Most reports describe the implant failing to bond with the jawbone or losing that bond, and some describe peri-implantitis, pain, or an abnormal opening forming around the implant. Reports fell from 9 in the prior 12 months to 3 in the latest 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
- 106
- Deaths reported
- 0
- Injuries reported
- 106
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 07640156471366), received between Feb 1, 2018 and Apr 7, 2026 — classified as 106 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (64 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 Osseointegrate64
- Loss of Osseointegration42
Patient problems
- Inadequate Osseointegration78
- No Code Available28
Recent adverse event reports
The 25 most recent of 106 reports, in the reporter's own words as published by the FDA.
InjuryApr 7, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, FISTULA, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24800698 ↗InjuryMar 6, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24528825 ↗InjuryJan 30, 2026Failure 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 24219354 ↗InjuryOct 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERI-IMPLANTITIS.
Patient problems: Inadequate Osseointegration
MAUDE report 23414957 ↗InjuryOct 23, 2025Loss 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, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 23364778 ↗InjuryAug 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERI-IMPLANTITIS, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 22860237 ↗InjuryAug 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SWELLING.
Patient problems: Inadequate Osseointegration
MAUDE report 22860023 ↗InjuryJun 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22193753 ↗InjuryMay 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, MOBILITY - ANOTHER SIZE OF IMPLANT WAS CHOSEN.
Patient problems: Inadequate Osseointegration
MAUDE report 21949134 ↗InjuryMar 19, 2025Loss 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, BRUXISM, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 21642197 ↗InjuryMar 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, PERI-IMPLANTITIS, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 21526432 ↗InjuryJan 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 21089261 ↗InjurySep 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, PERI-IMPLANTITIS, MOBILITY. (B)(6) ARE THE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 20155036 ↗InjuryAug 6, 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, INFECTION, ABSCESS, INFLAMMATION
Patient problems: Inadequate Osseointegration
MAUDE report 19917473 ↗InjuryAug 6, 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, INFECTION
Patient problems: Inadequate Osseointegration
MAUDE report 19917375 ↗InjuryAug 4, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, THREAD TAP USED, SMOKER.
Patient problems: Inadequate Osseointegration
MAUDE report 19902722 ↗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, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19902630 ↗InjuryAug 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19901317 ↗InjuryAug 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, INFECTION, PAIN, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19901275 ↗InjuryJul 21, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19787891 ↗InjuryJul 18, 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.
Patient problems: Inadequate Osseointegration
MAUDE report 19770075 ↗InjuryJul 18, 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, INFECTION, ABSCESS.
Patient problems: Inadequate Osseointegration
MAUDE report 19768630 ↗InjuryJul 17, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19761132 ↗InjuryJul 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19760787 ↗InjuryJul 17, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19760700 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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