FDA Adverse Event Injury Summary report: N

NEODENT IMPLANT HELIX GM ACQUA

MDR report key: 19003980 · Received March 28, 2024

Report

Report Number
MW5153367
Event Type
Injury
Date Received
March 28, 2024
Date of Event
November 14, 2023
Report Date
March 26, 2024
Manufacturer
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA
Product Code
DZE
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
SC, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAD TO HAVE A DENTAL IMPLANT PLACED DUE TO THE EXTRACTION OF A BROKEN TOOTH. TWO WEEKS AFTER THE IMPLANT WAS PLACED I STARTED EXPERIENCING SEVERE PAIN (SCREAMING PAIN), SWELLING, WHICH GOT WORSE AND EVENTUALLY I WAS UNABLE TO SWALLOW, MY SKIN TURNED DARK GRAY, MY GUMS AND MOUTH WERE DEEP DARK PURPLE AND EXTREMELY SWOLLEN. YOU COULDN'T SEE MY JAW LINE INSIDE MY MOUTH. I HAD BLACK CIRCLES UNDER MY EYES AND HAD TO HAVE EMERGENCY ORAL SURGERY TO HAVE THE IMPLANT REMOVED. THE ORAL SURGEON WAS NOT THE SAME DENTIST OR PART OF THE DENTAL GROUP THAT INITIALLY PLACED THE IMPLANT. THIS ORAL SURGEON SAID I WAS HAVING AN ALLERGIC REACTION TO THE ACTUAL IMPLANT. HE REMOVED IT IN ORDER TO PREVENT ANY MORE SERIOUS DAMAGE OR DEATH. I CALLED THE IMPLANT COMPANY, NEODENT/STRAUMANN, TO GET THE MATERIALS USED IN THE IMPLANT FOR ALLERGY TESTING. THE CUSTOMER/TECH SUPPORT PERSON, (B)(4), AT NEODENT/STRAUMANN SAID HE WAS NOT ALLOWED TO RELEASE THAT INFORMATION TO ME, BUT COULD RELEASE TO THE DENTIST WHO PLACED THE IMPLANT. HE ALSO SAID THAT THE FDA HAS A COPY OF THE MATERIAL SAFETY DATA SHEET ON FILE AS REQUIRED BY REGULATIONS. THE DENTIST WHO PLACED THE IMPLANT CONTACTED THE NEODENT/STRAUMANN REP WHO SAID THERE WASN'T SUCH A DOCUMENT. HE ALSO TRIED TO CALL THE CUSTOMER/TECH SUPPORT LINE AND WAS UNABLE TO GET ANY INFORMATION ABOUT WHAT WAS IN THE IMPLANT. I NEED TO KNOW, AND SO DO MY DOCTORS, WHAT EXACTLY THAT IMPLANT WAS MADE OF FOR FUTURE REFERENCE IN CASE I HAVE TO HAVE ANY JOINT REPLACEMENTS OR METAL PUT IN MY BODY. AS OF NOW, ALL ATTEMPTS SINCE MID DECEMBER 2023 HAVE TO GET THE EXACT MAKEUP OF THE IMPLANT THAT WAS PLACED HAVE BEEN IN VAIN. SINCE THIS WAS SO SERIOUS AND I COULD HAVE DIED, I NEED TO KNOW WHAT WAS IN THAT IMPLANT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1589167 NEODENT IMPLANT HELIX GM ACQUA IMPLANT, ENDOSSEOUS, ROOT-FORM DZE JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA 140.954 APHA8

Patients

Seq Age Sex Outcome Treatment
1 61 YR Female Life Threatening| R CALCIUM.| MELOXICAM.| MULTI VITAMIN.| PROTONIX.| TIZANIDINE.| TYLENOL.| ZETIA.