Reported Reactions

Manufacturers

Device manufacturer, as written on reports

Jjgc: medical device reports filed with FDA

234,327 reports name it as the manufacturer of the device involved, 2020–2026.

234,327
reports naming it as manufacturer
0.9% of all MAUDE reports
78,414
reports, 12 months to August 2026
54,534 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

234,327 medical device reports received by FDA give Jjgc as the manufacturer of the device involved, 0.9% of the MAUDE database, from February 2020 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

78,414 reports arrived in the 12 months to August 2026, up 44% from 54,534 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
GM Helix Implant,Ti,4.0X10Implant, endosseous, root-form10,0484,1620%
GM Helix Implant,Ti,3.5X10Implant, endosseous, root-form8,0942,8410%
GM Helix Implant,Ti,3.75X10Implant, endosseous, root-form7,2722,8900%
GM Helix Implant,Ti,4.3X10Implant, endosseous, root-form7,2252,7860%
GM Helix Implant,Ti,3.5X11.5Implant, endosseous, root-form6,6702,3560%
GM Helix Implant,Ti,3.75X11.5Implant, endosseous, root-form6,4972,5160%
GM Helix Implant,Ti,4.0X11.5Implant, endosseous, root-form6,3312,4140%
GM Helix Implant,Ti,4.0X8Implant, endosseous, root-form6,0052,6280%
GM Helix Acqua Implant,Ti,3.5X10Implant, endosseous, root-form5,4541,7740%
GM Helix Implant,Ti,4.3X8Implant, endosseous, root-form5,2392,3160%
GM Helix Acqua Implant,Ti,3.5X11.5Implant, endosseous, root-form5,1341,6010%
GM Helix Implant,Ti,4.0X13Implant, endosseous, root-form5,0312,0580%
GM Helix Acqua Implant,Ti,4.0X10Implant, endosseous, root-form5,0151,7930%
GM Helix Acqua Implant,Ti,3.5X13Implant, endosseous, root-form5,0101,3370%
GM Helix Implant,Ti,4.3X11.5Implant, endosseous, root-form4,6101,7000%
GM Helix Implant,Ti,3.5X13Implant, endosseous, root-form4,4231,5980%
GM Helix Implant,Ti,3.75X13Implant, endosseous, root-form4,3101,8230%
GM Helix Implant,Ti,3.5X8Implant, endosseous, root-form4,2871,5460%
GM Helix Implant,Ti,5.0X10Implant, endosseous, root-form4,1901,5300%
GM Helix Implant,Ti,5.0X8Implant, endosseous, root-form4,0121,7250%
GM Helix Acqua Implant,Ti,4.3X10Implant, endosseous, root-form3,9521,3160%
GM Helix Acqua Implant,Ti,4.3X13Implant, endosseous, root-form3,4239240%
GM Helix Implant,Ti,4.3X13Implant, endosseous, root-form3,3831,2430%
GM Helix Acqua Implant,Ti,3.75X10Implant, endosseous, root-form2,9471,3080%
GM Helix Acqua Implant,Ti,3.75X11.5Implant, endosseous, root-form2,9451,1760%
GM Helix Implant,Ti,3.75X8Implant, endosseous, root-form2,8031,4070%
GM Helix Acqua Implant,Ti,4.0X11.5Implant, endosseous, root-form2,5601,1300%
GM Helix Acqua Implant,Ti,4.0X8Implant, endosseous, root-form2,3991,1610%
GM Helix Acqua Implant,Ti,4.3X11.5Implant, endosseous, root-form2,0939940%
CM Alvim Impl Ti 3.5X10Implant, endosseous, root-form1,9062260%

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-form234,276100%
OATImplant, endosseous, orthodontic490%
DZADrill, dental, intraoral20%

Reports by month, five years

05,89311,785Sep 2021: 929Oct 2021: 405Nov 2021: 1,073Dec 2021: 1,2792022Jan 2022: 1,076Feb 2022: 1,045Mar 2022: 2,182Apr 2022: 1,729May 2022: 1,965Jun 2022: 1,799Jul 2022: 2,011Aug 2022: 2,720Sep 2022: 1,790Oct 2022: 3,279Nov 2022: 2,295Dec 2022: 2,1792023Jan 2023: 3,827Feb 2023: 1,767Mar 2023: 2,698Apr 2023: 2,728May 2023: 2,745Jun 2023: 2,564Jul 2023: 2,325Aug 2023: 2,835Sep 2023: 2,459Oct 2023: 2,961Nov 2023: 2,730Dec 2023: 2,5632024Jan 2024: 2,447Feb 2024: 2,504Mar 2024: 2,469Apr 2024: 3,906May 2024: 3,757Jun 2024: 3,707Jul 2024: 4,894Aug 2024: 5,756Sep 2024: 4,959Oct 2024: 4,993Nov 2024: 4,210Dec 2024: 4,8592025Jan 2025: 3,857Feb 2025: 3,749Mar 2025: 4,036Apr 2025: 2,296May 2025: 0Jun 2025: 11,785Jul 2025: 4,957Aug 2025: 4,833Sep 2025: 5,066Oct 2025: 6,193Nov 2025: 5,401Dec 2025: 9,4802026Jan 2026: 5,800Feb 2026: 5,876Mar 2026: 6,972Apr 2026: 5,836May 2026: 6,619Jun 2026: 7,300Jul 2026: 6,902Aug 2026: 6,969

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

Event type

Death0%0
Injury100%234,327
Malfunction0%0
Other0%0
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 Jjgc reports

How many FDA device reports name Jjgc as manufacturer?

234,327 reports through August 2026, 78,414 of them in the latest 12 months.

Which of its brands appear most often?

GM Helix Implant,Ti,4.0X10 (10,048), GM Helix Implant,Ti,3.5X10 (8,094), GM Helix Implant,Ti,3.75X10 (7,272), GM Helix Implant,Ti,4.3X10 (7,225) and GM Helix Implant,Ti,3.5X11.5 (6,670).

Which device types does it report on?

implant, endosseous, root-form (100%), implant, endosseous, orthodontic (0%) and drill, dental, intraoral (0%).

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.