SPI ELEMENT 4.13.914Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
Quick summary
This Thommen SPI Element dental implant has 232 adverse event reports, including 232 injuries and no deaths. The reports mostly describe the implant failing to bond with the bone or losing that bond, with some patients reporting pain and swelling. Reports fell from 20 in the previous 12 months to 0 in 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
- 232
- Deaths reported
- 0
- Injuries reported
- 232
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 232 adverse event reports that list this exact device (DI 07640156471465), received between Feb 1, 2018 and Oct 27, 2025 — classified as 232 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (194 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 Osseointegrate194
- Loss of Osseointegration37
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Inadequate Osseointegration166
- No Code Available65
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 232 reports, in the reporter's own words as published by the FDA.
InjuryOct 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 23388709 ↗InjuryJul 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22585612 ↗InjuryJul 24, 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, BONE RESORPTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22585140 ↗InjuryJun 27, 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, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22345036 ↗InjuryJun 27, 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, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22345033 ↗InjuryJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMMEDIATE IMPLANTATION, PAIN, SWELLING, ABSCESS, INFLAMMATION, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 22344909 ↗InjuryJun 26, 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, INFECTION, PAIN, SWELLING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22335218 ↗InjuryJan 6, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PAIN, INFLAMMATION, MOBILITY (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 21079790 ↗InjuryNov 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, SMOKER, COMPLICATION IN SITE PREPARATION
Patient problems: Inadequate Osseointegration
MAUDE report 20809361 ↗InjuryNov 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20805363 ↗InjuryNov 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, XEROSTOMIA, IMMEDIATE IMPLANTATION, SWELLING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20805037 ↗InjuryNov 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PAIN
Patient problems: Inadequate Osseointegration
MAUDE report 20803920 ↗InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, SMOKER, PERIODONTAL DISEASE, IMMEDIATE IMPLANTATION, UNDERSIZED IMPLANT BED, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 20664223 ↗InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 20661843 ↗InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED; NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 20661656 ↗InjuryNov 11, 2024Failure 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, SMOKER.
Patient problems: Inadequate Osseointegration
MAUDE report 20651241 ↗InjuryNov 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, PERIODONTAL DISEASE, BONE RESORPTION, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 20618280 ↗InjuryNov 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE.
Patient problems: Inadequate Osseointegration
MAUDE report 20610015 ↗InjuryNov 5, 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, PAIN (2024_3432 AND 2024_3433 ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 20609978 ↗InjuryNov 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, INFECTION, PAIN, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20566122 ↗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, BONE RESORPTION.
Patient problems: Inadequate Osseointegration
MAUDE report 20565982 ↗InjuryOct 30, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, DIABETES MELLITUS, INFECTION.
Patient problems: Inadequate Osseointegration
MAUDE report 20564737 ↗InjuryOct 28, 2024Failure 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, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20544011 ↗InjuryOct 22, 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, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, INFECTION, FISTULA, INFLAMMATION, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 20504251 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.