SPI ELEMENT INICELL 4.23.515Recalls & reported problems
Thommen Medical AG · Class 2 · Implant
All models of SPI ELEMENT INICELL (67)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Thommen SPI Element implant has 123 adverse event reports, with no deaths and 123 injuries. Most reports describe implants that did not bond with bone, and some note smoking, diabetes or infection, with some implants lost. Reports fell from 17 in the previous year to 9 in the latest year. 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
- 124
- Deaths reported
- 0
- Injuries reported
- 124
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 07640156470284), received between Feb 15, 2018 and Sep 28, 2026 — classified as 124 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (99 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate99
- Loss of Osseointegration23
- Loosening of Implant Not Related to Bone-Ingrowth2
Patient problems
- Inadequate Osseointegration83
- No Code Available39
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 25 most recent of 124 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant wasn't completely covered with bone, immediate implantation ((b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50912001 ↗InjuryAug 27, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, smoker ((b)(6) and (b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50473265 ↗InjuryAug 11, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant wasn't completely covered with bone, no thread tap used, local infection / subacute chronic osteitis, immediate implantation, inadequate bone quality/quantity, preceding/simultaneous bone augmentation, infection, fistula, abscess.
Patient problems: Inadequate Osseointegration
MAUDE report 50207458 ↗InjuryMay 28, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, DIABETES MELLITUS, TRAUMA / ACCIDENT, IMMEDIATE IMPLANTATION, INCREASED SENSITIVITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25315515 ↗InjuryMay 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, PAIN, SWELLING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25214935 ↗InjuryMar 23, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24661377 ↗InjuryJan 22, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, TRAUMA / ACCIDENT, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24144042 ↗InjuryJan 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, ABSCESS, BLEEDING (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24107452 ↗InjuryJan 12, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, ABSCESS, BLEEDING (2026_0139 AND 0140 ARE SAME PATIENT)
Patient problems: Inadequate Osseointegration
MAUDE report 24036173 ↗InjuryNov 6, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, PERI-IMPLANTITIS, INCREASED SENSITIVITY, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 23483973 ↗InjuryAug 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22920957 ↗InjuryAug 25, 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, INADEQUATE BONE QUALITY/QUANTITY, PERI-IMPLANTITIS, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22882438 ↗InjuryAug 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22882403 ↗InjuryAug 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, IMMEDIATE IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22802162 ↗InjuryAug 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, INFECTION, PAIN, SWELLING, BLEEDING, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22735822 ↗InjuryJul 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 22368951 ↗InjuryJun 17, 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, AND BONE RESORPTION.
Patient problems: Inadequate Osseointegration
MAUDE report 22222754 ↗InjuryMay 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 21983908 ↗InjuryMar 19, 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, PSYCHOLOGICAL DISORDER, SMOKER, PERIODONTAL DISEASE.
Patient problems: Inadequate Osseointegration
MAUDE report 21641303 ↗InjuryFeb 6, 2025Failure 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, DRUG OR ALCOHOL ABUSE, XEROSTOMIA, SMOKER, PERI-IMPLANTITIS, MOBILITY ((B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 21320292 ↗InjuryFeb 6, 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.
Patient problems: Inadequate Osseointegration
MAUDE report 21320088 ↗InjuryFeb 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 21319629 ↗InjuryFeb 6, 2025Failure 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, DRUG OR ALCOHOL ABUSE, XEROSTOMIA, SMOKER, INFECTION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 21319616 ↗InjuryJan 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, BLEEDING, INFLAMMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 21272520 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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