SPI ELEMENT 4.13.940Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
Quick summary
This Thommen SPI Element dental implant is a root-form implant placed into bone. Its 152 adverse event reports are all listed as injuries, with no deaths, and many describe implants that did not fuse with the bone or were lost, often where the implant was not firmly anchored when placed. Reports fell to 1 in the past 12 months from 7 before. 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
- 152
- Deaths reported
- 0
- Injuries reported
- 152
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 07640156471380), received between Feb 2, 2018 and May 26, 2026 — classified as 152 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (124 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 Osseointegrate124
- Loss of Osseointegration27
- Break1
Patient problems
- Inadequate Osseointegration109
- No Code Available43
Recent adverse event reports
The 25 most recent of 152 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 25276525 ↗InjuryJun 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMMEDIATE IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22335138 ↗InjuryJun 26, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 22334714 ↗InjuryMay 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PAIN, SWELLING, BLEEDING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22085435 ↗InjuryMar 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 21676742 ↗InjuryJan 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PAIN, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 21089011 ↗InjuryNov 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, IMMEDIATE IMPLANTATION, SWELLING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20808845 ↗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, PERIODONTAL DISEASE, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, INADEQUATE BONE QUALITY/QUANTITY, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, BONE RESORPTION, INFECTION, PAIN, NUMBNESS, INCREASED SENSITIVITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 20721524 ↗InjuryOct 30, 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 20566408 ↗InjuryOct 25, 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, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, PAIN, SWELLING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20530934 ↗InjuryOct 24, 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, PAIN, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 20520475 ↗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 20512729 ↗InjuryAug 15, 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, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19989733 ↗InjuryAug 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
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 (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 19902628 ↗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 (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 19902627 ↗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 (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 19902626 ↗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, PERI-IMPLANTITIS, INFECTION, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19902538 ↗InjuryJul 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19760763 ↗InjuryJul 16, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERIODONTAL DISEASE.
Patient problems: Inadequate Osseointegration
MAUDE report 19749291 ↗InjuryJul 11, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, UNCONTROLLED ENDOCRINE ILLNESS, PERIODONTAL DISEASE, IMMEDIATE IMPLANTATION, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 19717525 ↗InjuryJun 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, DIABETES MELLITUS, SMOKER, PERI-IMPLANTITIS ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 19481271 ↗InjuryJun 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, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, BONE RESORPTION.
Patient problems: Inadequate Osseointegration
MAUDE report 19457423 ↗InjuryJun 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, FISTULA.
Patient problems: Inadequate Osseointegration
MAUDE report 19456978 ↗InjuryMay 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, SINUS PERFORATION
Patient problems: Inadequate Osseointegration
MAUDE report 19381416 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.