Reported Reactions

Manufacturers

Device manufacturer, as written on reports

Thommen Medical: medical device reports filed with FDA

21,205 reports name it as the manufacturer of the device involved, 2018–2026.

21,205
reports naming it as manufacturer
0.1% of all MAUDE reports
2,360
reports, 12 months to August 2026
2,945 in the 12 months before
0%
classified as malfunction
62.3% across all reports
0%
classified as death, as reported
0.9% across all reports

21,205 medical device reports received by FDA give Thommen Medical as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 2018 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

2,360 reports arrived in the 12 months to August 2026, down 20% from 2,945 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (100%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

BrandDevice typeReportsLatest 12 monthsClassified as death
Element Mc InicellImplant, endosseous, root-form1,218930.1%
Element Rc Inicell Pf 4 0 E 4 0 L9 5Implant, endosseous, root-form1,1231410%
Element Rc Inicell Pf 4 0 E 4 0 L8 0Implant, endosseous, root-form9911540%
Element Rc Inicell Pf 4 5 E 4 2 L9 5Implant, endosseous, root-form886970%
Element Rc Inicell Pf 4 5 E 4 2 L8 0Implant, endosseous, root-form733800%
Element Rc Inicell Pf 4 0 E 4 0 L11 0Implant, endosseous, root-form677540%
Element Rc Inicell Pf 3 5 E 3 5 L9 5Implant, endosseous, root-form644610%
Element Rc Inicell Pf 5 0 E 5 0 L8 0Implant, endosseous, root-form580720%
Element Rc InicellImplant, endosseous, root-form502310%
Element Rc Inicell Pf 5 0 E 5 0 L9 5Implant, endosseous, root-form497620%
Element Rc Inicell Pf 3 5 E 3 5 L11 0Implant, endosseous, root-form473440%
Element Rc Inicell Pf 4 5 E 4 2 L11 0Implant, endosseous, root-form472500%
Element Rc Inicell Pf 3 5 E 3 5 L8 0Implant, endosseous, root-form399400%
Element Mc Inicell Pf 4 0 E 4 0 L9 5Implant, endosseous, root-form395680%
Element Rc Inicell Pf 4 0 E 4 0 L6 5Implant, endosseous, root-form354340%
Element Mc Inicell Pf 3 5 E 3 5 L9 5Implant, endosseous, root-form313310%
Element Mc Inicell Pf 4 0 E 4 0 L11 0Implant, endosseous, root-form303540%
Element Mc Inicell Pf 3 5 E 3 5 L11 0Implant, endosseous, root-form293290%
Element Mc Inicell Pf 4 5 E 4 2 L9 5Implant, endosseous, root-form281450%
Element Rc Inicell Pf 4 0 E 4 0 L12 5Implant, endosseous, root-form265250%
Element Rc Inicell Pf 4 5 E 4 2 L6 5Implant, endosseous, root-form265440%
Contact Mc Inicell Pf 4 0 E 3 5 L11 0Implant, endosseous, root-form234500%
Element Rc Inicell Pf 5 0 E 5 0 L6 5Implant, endosseous, root-form234250%
Contact Mc InicellImplant, endosseous, root-form220190%
Element Impl Pf 4 0 E 4 0 L 9 5Implant, endosseous, root-form20210%
Element Impl Pf 4 5 E 4 2 L 9 5Implant, endosseous, root-form14590%
Element Mc Inicell Pf 4 5 E 4 2 L11 0Implant, endosseous, root-form129220%
Element Impl Pf 4 0 E 4 0 L 8 0Implant, endosseous, root-form11310%
Element Mc Inicell Pf 4 0 E 4 0 L8 0Implant, endosseous, root-form110370%
Element Mc Inicell Pf 5 0 E 5 0 L9 5Implant, endosseous, root-form107290%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product codeDevice typeReportsShare
DZEImplant, endosseous, root-form21,205100%

Reports by month, five years

0228455Sep 2021: 233Oct 2021: 34Nov 2021: 167Dec 2021: 2732022Jan 2022: 257Feb 2022: 220Mar 2022: 267Apr 2022: 292May 2022: 97Jun 2022: 82Jul 2022: 283Aug 2022: 290Sep 2022: 198Oct 2022: 173Nov 2022: 257Dec 2022: 932023Jan 2023: 180Feb 2023: 216Mar 2023: 157Apr 2023: 198May 2023: 314Jun 2023: 375Jul 2023: 291Aug 2023: 235Sep 2023: 152Oct 2023: 222Nov 2023: 155Dec 2023: 1782024Jan 2024: 386Feb 2024: 363Mar 2024: 203Apr 2024: 363May 2024: 289Jun 2024: 396Jul 2024: 373Aug 2024: 241Sep 2024: 455Oct 2024: 321Nov 2024: 177Dec 2024: 372025Jan 2025: 304Feb 2025: 297Mar 2025: 257Apr 2025: 184May 2025: 278Jun 2025: 181Jul 2025: 171Aug 2025: 283Sep 2025: 210Oct 2025: 146Nov 2025: 242Dec 2025: 422026Jan 2026: 395Feb 2026: 163Mar 2026: 205Apr 2026: 226May 2026: 154Jun 2026: 198Jul 2026: 249Aug 2026: 130

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0%1
Injury100%21,199
Malfunction0%3
Other0%2
Not given0%0

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Thommen Medical reports

How many FDA device reports name Thommen Medical as manufacturer?

21,205 reports through August 2026, 2,360 of them in the latest 12 months.

Which of its brands appear most often?

Element Mc Inicell (1,218), Element Rc Inicell Pf 4 0 E 4 0 L9 5 (1,123), Element Rc Inicell Pf 4 0 E 4 0 L8 0 (991), Element Rc Inicell Pf 4 5 E 4 2 L9 5 (886) and Element Rc Inicell Pf 4 5 E 4 2 L8 0 (733).

Which device types does it report on?

implant, endosseous, root-form (100%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.