SPI ELEMENT INICELLRecalls & reported problems across all models
Thommen Medical AG · 67 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13,500
- Deaths reported
- 0
- Injuries reported
- 13,499
- Recalls
- 0
We found 67 models of SPI ELEMENT INICELL by Thommen Medical AG in the FDA's device registry (GUDID). Together they are named in 13,500 adverse event reports in the FDA's MAUDE database, received between Jan 7, 2018 and Sep 30, 2026 — classified as 13,499 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (10,466 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SPI ELEMENT INICELL problems
Device problems
- Failure to Osseointegrate10,466
- Loss of Osseointegration2,923
- Loosening of Implant Not Related to Bone-Ingrowth63
- Break24
- Patient-Device Incompatibility5
- Unstable5
- Adverse Event Without Identified Device or Use Problem3
- Appropriate Device Problem Term/Code Not Available3
Patient problems
- Inadequate Osseointegration9,613
- No Code Available3,806
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available58
- Implant Pain7
- Failure of Implant1
SPI ELEMENT INICELL models
67 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SPI ELEMENT INICELL 4.23.123Implant, Endosseous, Root-Form1,169 reports
- SPI ELEMENT INICELL 4.23.122Implant, Endosseous, Root-Form968 reports
- SPI ELEMENT INICELL 4.23.133Implant, Endosseous, Root-Form894 reports
- SPI ELEMENT INICELL 4.23.124Implant, Endosseous, Root-Form731 reports
- SPI ELEMENT INICELL 4.23.132Implant, Endosseous, Root-Form719 reports
- SPI ELEMENT INICELL 4.23.113Implant, Endosseous, Root-Form674 reports
- SPI ELEMENT INICELL 4.23.142Implant, Endosseous, Root-Form583 reports
- SPI ELEMENT INICELL 4.23.143Implant, Endosseous, Root-Form509 reports
- SPI ELEMENT INICELL 4.23.134Implant, Endosseous, Root-Form482 reports
- SPI ELEMENT INICELL 4.23.114Implant, Endosseous, Root-Form481 reports
- SPI ELEMENT INICELL 4.23.523Implant, Endosseous, Root-Form405 reports
- SPI ELEMENT INICELL 4.23.112Implant, Endosseous, Root-Form398 reports
- SPI ELEMENT INICELL 4.23.121Implant, Endosseous, Root-Form349 reports
- SPI ELEMENT INICELL 4.23.524Implant, Endosseous, Root-Form319 reports
- SPI ELEMENT INICELL 4.23.513Implant, Endosseous, Root-Form318 reports
- SPI ELEMENT INICELL 4.23.533Implant, Endosseous, Root-Form313 reports
- SPI ELEMENT INICELL 4.23.514Implant, Endosseous, Root-Form307 reports
- SPI ELEMENT INICELL 4.23.125Implant, Endosseous, Root-Form304 reports
- SPI ELEMENT INICELL 4.23.131Implant, Endosseous, Root-Form284 reports
- SPI ELEMENT INICELL 4.23.141Implant, Endosseous, Root-Form257 reports
- SPI ELEMENT INICELL 4.23.534Implant, Endosseous, Root-Form223 reports
- SPI ELEMENT INICELL 4.23.543Implant, Endosseous, Root-Form208 reports
- SPI ELEMENT INICELL 4.23.115Implant, Endosseous, Root-Form203 reports
- SPI ELEMENT INICELL 4.23.522Implant, Endosseous, Root-Form197 reports
- SPI ELEMENT INICELL 4.23.144Implant, Endosseous, Root-Form197 reports
- SPI ELEMENT INICELL 4.23.542Implant, Endosseous, Root-Form191 reports
- SPI ELEMENT INICELL 4.23.532Implant, Endosseous, Root-Form173 reports
- SPI ELEMENT INICELL 4.23.135Implant, Endosseous, Root-Form165 reports
- SPI ELEMENT INICELL 4.23.525Implant, Endosseous, Root-Form149 reports
- SPI ELEMENT INICELL 4.23.515Implant, Endosseous, Root-Form124 reports
- SPI ELEMENT INICELL 4.23.512Implant, Endosseous, Root-Form110 reports
- SPI ELEMENT INICELL 4.23.544Implant, Endosseous, Root-Form80 reports
- SPI ELEMENT INICELL 4.23.535Implant, Endosseous, Root-Form78 reports
- SPI ELEMENT INICELL 4.23.152Implant, Endosseous, Root-Form75 reports
- SPI ELEMENT INICELL 4.23.153Implant, Endosseous, Root-Form72 reports
- SPI ELEMENT INICELL 4.23.151Implant, Endosseous, Root-Form65 reports
- SPI ELEMENT INICELL 4.23.126Implant, Endosseous, Root-Form62 reports
- SPI ELEMENT INICELL 4.23.145Implant, Endosseous, Root-Form59 reports
- SPI ELEMENT INICELL 4.23.545Implant, Endosseous, Root-Form58 reports
- SPI ELEMENT INICELL 4.23.116Implant, Endosseous, Root-Form56 reports
- SPI ELEMENT INICELL 4.23.104Implant, Endosseous, Root-Form51 reports
- SPI ELEMENT INICELL 4.23.136Implant, Endosseous, Root-Form46 reports
- SPI ELEMENT INICELL 4.23.103Implant, Endosseous, Root-Form40 reports
- SPI ELEMENT INICELL 4.23.553Implant, Endosseous, Root-Form36 reports
- SPI ELEMENT INICELL 4.23.552Implant, Endosseous, Root-Form35 reports
- SPI ELEMENT INICELL 4.23.723Implant, Endosseous, Root-Form34 reports
- SPI ELEMENT INICELL 4.23.526Implant, Endosseous, Root-Form32 reports
- SPI ELEMENT INICELL 4.23.536Implant, Endosseous, Root-Form25 reports
- SPI ELEMENT INICELL 4.23.722Implant, Endosseous, Root-Form24 reports
- SPI ELEMENT INICELL 4.23.516Implant, Endosseous, Root-Form22 reports
- SPI ELEMENT INICELL 4.23.724Implant, Endosseous, Root-Form19 reports
- SPI ELEMENT INICELL 4.23.105Implant, Endosseous, Root-Form17 reports
- SPI ELEMENT INICELL 4.23.154Implant, Endosseous, Root-Form16 reports
- SPI ELEMENT INICELL 4.23.554Implant, Endosseous, Root-Form12 reports
- SPI ELEMENT INICELL 4.23.102Implant, Endosseous, Root-Form12 reports
- SPI ELEMENT INICELL 4.23.714Implant, Endosseous, Root-Form11 reports
- SPI ELEMENT INICELL 4.23.713Implant, Endosseous, Root-Form9 reports
- SPI ELEMENT INICELL 4.23.712Implant, Endosseous, Root-Form9 reports
- SPI ELEMENT INICELL 4.23.546Implant, Endosseous, Root-Form8 reports
- SPI ELEMENT INICELL 4.23.146Implant, Endosseous, Root-Form7 reports
- SPI ELEMENT INICELL 4.23.721Implant, Endosseous, Root-Form6 reports
- SPI ELEMENT INICELL 4.23.137Implant, Endosseous, Root-Form5 reports
- SPI ELEMENT INICELL 4.23.725Implant, Endosseous, Root-Form4 reports
- SPI ELEMENT INICELL 4.23.117Implant, Endosseous, Root-Form4 reports
- SPI ELEMENT INICELL 4.23.715Implant, Endosseous, Root-Form3 reports
- SPI ELEMENT INICELL 4.23.155Implant, Endosseous, Root-Form3 reports
- SPI ELEMENT INICELL 4.23.726Implant, Endosseous, Root-Form1 report
Recent SPI ELEMENT INICELL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, immediate implantation, pain, inflammation.
Patient problems: Inadequate Osseointegration
MAUDE report 50943166 ↗InjurySep 29, 2026Failure to Osseointegrate
Primary stability not achieved, implant was completely covered with bone, no thread tap used - another size of implant was chosen.
Patient problems: Inadequate Osseointegration
MAUDE report 50931051 ↗InjurySep 29, 2026Failure to Osseointegrate
Primary stability not achieved, implant wasn't completely covered with bone, no thread tap used, inadequate bone quality/quantity, preceding/simultaneous bone augmentation, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50930938 ↗InjurySep 29, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, smoker, peri-implantitis, inflammation.
Patient problems: Inadequate Osseointegration
MAUDE report 50930783 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50930762 ↗InjurySep 28, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, smoker, bone resorption, bleeding ((b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50913211 ↗InjurySep 28, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, smoker, peri-implantitis, pain, mobility ((b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50913174 ↗InjurySep 28, 2026Failure to Osseointegrate
Primary stability not achieved, implant was completely covered with bone, no thread tap used.
Patient problems: Inadequate Osseointegration
MAUDE report 50912515 ↗InjurySep 28, 2026Failure to Osseointegrate
Primary stability not achieved, periodontal disease, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50912495 ↗InjurySep 28, 2026Failure to Osseointegrate
Primary stability not achieved, implant wasn't completely covered with bone, no thread tap used.
Patient problems: Inadequate Osseointegration
MAUDE report 50912401 ↗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 50912004 ↗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 50912002 ↗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 ↗InjurySep 28, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, bone resorption, peri-implantitis, infection, inflammation, mobility ((b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50911738 ↗InjurySep 28, 2026Failure to Osseointegrate
Implant didn't achieve osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, bone resorption, peri-implantitis, infection, inflammation, mobility ((b)(6) are same patient).
Patient problems: Inadequate Osseointegration
MAUDE report 50911729 ↗
Other Thommen Medical AG products
All Thommen Medical AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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