SPI ELEMENT 4.13.904Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
Quick summary
This Thommen SPI Element dental implant is a device placed into the jawbone. Most of the 179 reports describe the implant failing to bond with the bone, and the reports include 179 injuries and no deaths. Reports from the last 12 months number 1, compared with 21 in the 12 months 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
- 179
- Deaths reported
- 0
- Injuries reported
- 179
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 07640156471502), received between Feb 16, 2018 and May 19, 2026 — classified as 179 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (151 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 Osseointegrate151
- Loss of Osseointegration27
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Inadequate Osseointegration144
- No Code Available35
Recent adverse event reports
The 25 most recent of 179 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2026Loss of Osseointegration
InjuryOct 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23307943 ↗InjuryJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, INFECTION, SWELLING ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 22345469 ↗InjuryJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, INFECTION, SWELLING ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 22345465 ↗InjuryJun 27, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, PERIODONTAL DISEASE, PERI-IMPLANTITIS
Patient problems: Inadequate Osseointegration
MAUDE report 22345342 ↗InjuryJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, IMMEDIATE IMPLANTATION, UNDERSIZED IMPLANT BED, INADEQUATE BONE QUALITY/QUANTITY, PAIN, BLEEDING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22345190 ↗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, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 22335257 ↗InjuryJun 26, 2025Failure 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, SWELLING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22335016 ↗InjuryDec 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20852116 ↗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 20808783 ↗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 20805545 ↗InjuryNov 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, COMPLICATION IN SITE PREPARATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20805312 ↗InjuryNov 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, COMPLICATION IN SITE PREPARATION, IMMEDIATE IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20805211 ↗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.
Patient problems: Inadequate Osseointegration
MAUDE report 20721507 ↗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, SMOKER, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20721262 ↗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, SMOKER, PERI-IMPLANTITIS
Patient problems: Inadequate Osseointegration
MAUDE report 20721254 ↗InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, INFECTION, SWELLING, FISTULA.
Patient problems: Inadequate Osseointegration
MAUDE report 20664877 ↗InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED; NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 20661676 ↗InjuryNov 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20651501 ↗InjuryNov 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE.
Patient problems: Inadequate Osseointegration
MAUDE report 20650687 ↗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 20618460 ↗InjuryNov 6, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, PAIN, SWELLING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 20618420 ↗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, INADEQUATE BONE QUALITY/QUANTITY, PAIN, MOBILITY (B)(6) ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 20520972 ↗InjuryOct 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 20512852 ↗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, PERI-IMPLANTITIS, INFECTION, PAIN, FISTULA, INFLAMMATION, MOBILITY
Patient problems: Inadequate Osseointegration
MAUDE report 20504344 ↗
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.