SPI ELEMENT 4.13.941Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
Quick summary
This Thommen SPI Element implant has 193 reports, all of them injuries, and no deaths. Nearly all describe the implant not bonding with the bone or losing that bond, and some mention pain or gum infection around the implant. Reports fell from 16 in the prior 12 months to 5 in the most recent 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
- 194
- Deaths reported
- 0
- Injuries reported
- 194
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 194 adverse event reports that list this exact device (DI 07640156471373), received between Feb 1, 2018 and Sep 28, 2026 — classified as 194 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (148 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 Osseointegrate148
- Loss of Osseointegration40
- Break6
Patient problems
- Inadequate Osseointegration133
- No Code Available56
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Failure of Implant2
Recent adverse event reports
The 25 most recent of 194 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, pain, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50911095 ↗InjuryApr 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 24856738 ↗InjuryApr 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERIODONTAL DISEASE, PERI-IMPLANTITIS, MOBILITY (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24855196 ↗InjuryApr 7, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PAIN, SWELLING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24800832 ↗InjuryJan 30, 2026Break
IMPLANT FRACTURE, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, BRUXISM.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24220477 ↗InjuryJan 30, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 24219332 ↗InjuryOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23300230 ↗InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERI-IMPLANTITIS (B)(6) ARE SAME PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 23300019 ↗InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PERI-IMPLANTITIS ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 23299253 ↗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, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22860207 ↗InjuryJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22345520 ↗InjuryJun 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22319430 ↗InjuryMay 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, SMOKER, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22007744 ↗InjuryMay 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22000569 ↗InjuryMar 5, 2025Loss 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, PERIODONTAL DISEASE, PRECEDING/SIMULTANEOUS BONE AUGMENTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 21523537 ↗InjuryJan 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 21190171 ↗InjuryNov 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, INADEQUATE BONE QUALITY/QUANTITY, BONE RESORPTION (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 20808782 ↗InjuryNov 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION
Patient problems: Inadequate Osseointegration
MAUDE report 20805559 ↗InjuryNov 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, COMPLICATION IN SITE PREPARATION
Patient problems: Inadequate Osseointegration
MAUDE report 20805374 ↗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 20661851 ↗InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 20661833 ↗InjuryNov 11, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, PAIN, BLEEDING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20650198 ↗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 ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 20544226 ↗InjuryOct 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, SMOKER, PAIN, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20544152 ↗InjuryOct 25, 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, BIOMECHANICAL OVERLOAD, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 20530873 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.