SPI ELEMENT 4.13.924Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
Quick summary
This Thommen SPI Element dental implant has 175 adverse event reports, with no deaths and 175 injuries. The reports mostly describe the implant failing to fuse with the jawbone, sometimes with weak initial stability after placement, and some report infection, swelling, and pain. No recalls name this device, and reports fell to 2 in the latest 12 months from 11 in the prior 12 months.
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
- 176
- Deaths reported
- 0
- Injuries reported
- 176
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 176 adverse event reports that list this exact device (DI 07640156471427), received between Feb 16, 2018 and Sep 28, 2026 — classified as 176 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (137 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 Osseointegrate137
- Loss of Osseointegration39
Patient problems
- Inadequate Osseointegration128
- No Code Available48
Recent adverse event reports
The 25 most recent of 176 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, bone resorption, peri-implantitis, pain, swelling, abscess.
Patient problems: Inadequate Osseointegration
MAUDE report 50913105 ↗InjuryMar 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, INFECTION.
Patient problems: Inadequate Osseointegration
MAUDE report 24638013 ↗InjuryMar 5, 2026Loss of Osseointegration
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, BLEEDING.
Patient problems: Inadequate Osseointegration
MAUDE report 22859989 ↗InjuryJul 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22319390 ↗InjuryMay 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, INFECTION, PAIN, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 21959384 ↗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 21949102 ↗InjuryMar 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 29, 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, INFECTION, FISTULA.
Patient problems: Inadequate Osseointegration
MAUDE report 20808850 ↗InjuryNov 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20804999 ↗InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20663923 ↗InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20661867 ↗InjuryOct 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, SMOKER, INADEQUATE BONE QUALITY/QUANTITY, PERI-IMPLANTITIS, INFECTION, BLEEDING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20565050 ↗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, PERI-IMPLANTITIS, PAIN, ABSCESS.
Patient problems: Inadequate Osseointegration
MAUDE report 20564634 ↗InjuryOct 30, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFECTION.
Patient problems: Inadequate Osseointegration
MAUDE report 20564621 ↗InjuryOct 24, 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, PAIN, SWELLING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20520543 ↗InjuryOct 24, 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 20520431 ↗InjuryOct 24, 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, NERVE ENCROACHMENT, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 20520423 ↗InjuryOct 24, 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 20520240 ↗InjuryOct 24, 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 20520235 ↗InjuryOct 24, 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, COMPLICATION IN SITE PREPARATION, IMMEDIATE IMPLANTATION, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20520207 ↗InjuryOct 24, 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
Patient problems: Inadequate Osseointegration
MAUDE report 20519956 ↗InjuryOct 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, PERIODONTAL DISEASE.
Patient problems: Inadequate Osseointegration
MAUDE report 20519940 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.