Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JJGC S.A. GM Helix Implant,Ti,4.3X13; Endosseous Dental Implant
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

JJGC S.A. GM Helix Implant,Ti,4.3X13; Endosseous Dental Implant Back to Search Results
Catalog Number 109.951
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 07/21/2026
Type of Reportable Event Serious Injury
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GM Helix Implant,Ti,4.3X13
Common Device Name
Endosseous Dental Implant
Manufacturer (Section D)
JJGC S.A.
av. juscelino kubitschek de
oliveira, 3291 cic
curitiba PR 81270 -200
BR  81270-200
MDR Report Key50824224
Report Number0001222315-2026-002877
Device Sequence Number10157932
Product Code DZE
UDI-Device Identifier07899878024224
UDI-Public07899878024224
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
Summary Report (Y/N)N
Device Implanted Year2026
Device Explanted Year2026
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 09/18/2026
Report Date (Section F) 09/18/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number109.951
Device Lot NumberTCRJ6
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/25/2026
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/18/2026
Device Age10 MO
Event Location Other
Date Report to Manufacturer08/25/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/18/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexMale
-
-