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 Lg Implant, Ti, 3.75x22.5; 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 Lg Implant, Ti, 3.75x22.5; Endosseous Dental Implant Back to Search Results
Catalog Number 109.1044
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/13/2026
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted 2025-(b)(6) in ada 15.On 2026-(b)(6), non-osseointegration was verified.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
Gm Helix Lg Implant, Ti, 3.75x22.5
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 Key50258065
Report Number0001222315-2026-002451
Device Sequence Number13430003
Product Code DZE
UDI-Device Identifier07899878031925
UDI-Public07899878031925
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
Summary Report (Y/N)N
Device Implanted Year2025
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) 08/14/2026
Report Date (Section F) 08/14/2026
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 Number109.1044
Device Lot NumberMWYY3
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/21/2026
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/14/2026
Device Age13 MO
Event Location Other
Date Report to Manufacturer07/21/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/14/2026
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
-
-