inforMED
InjuryDZE

BLUE SKY BIO MAX - DENTAL IMPLANT, BLUE SKY BIO INTERNAL HEX

Received Feb 5, 2024 · Event occurred Oct 3, 2022

Report MW5151071 · MDR key 18649893

Device

Generic name

Implant, Endosseous, Root-form

Manufacturer

Blue Sky Bio Llc.

Patient

27 YR · Female

  • Asthma
  • Hypersensitivity/Allergic reaction
  • Weight Changes
  • Cough
  • Asthma
  • Hypersensitivity/Allergic reaction
  • Weight Changes
  • Cough

Narrative

Description of Event or Problem

ADVERSE EFFECTS OF DENTAL IMPLANT AND CROWN MATERIALS. IN THE FIRST DENTAL IMPLANT (BLUE SKY BIO MAX) IN (B)(6) 2022. STARTING THE FOLLOWING MONTH I STARTED COUGHING WITH PHLEM. I PUT IT OFF THINKING I GOT COVID. THEN FAST FORWARD I GET THE CROWN. STILL COUGHING. THEN I GET MY 2ND DENTAL IMPLANT IN (B)(6) 2023. COUGH CONTINUED WITHOUT RESOLVED. SPOKE TO WITH AN ALLERGIST AND HE DID NOT KNOW WHAT COULD BE THE ISSUE. SPOKE WITH MY DENTIST HE KEPT STATING ITS NOT THE DENTAL IMPLANT. WENT BACK TO THE ALLERGIST AND WE DID A SKIN TEST. WITH THE DENTAL CROWN (EMAX) AND A TITANIUM DISK. AFTER A WEEK THE TITANIUM DISK IS FINE. HOWEVER I HAD A TYPE IV REACTION. WHERE MY SKIN SLOSHED OFF. I GAVE THE RESULTS TO MY DENTIST AND HE DENIED THAT I MAYBE ALLERGIC TO THE CROWN. MY DENTIST DID NOT OFFER ANY SOLUTIONS. LAST DECEMBER I VISITED MY REGULAR DR AND ADVISED ALL OF MY SYMPTOMS AND SHE SAID IT COULD BE ASTHMA. WE DID A INHALOR AND IT HAS HELPED. BUT I AM STILL SUFFERING WITH THE DENTAL IMPLANTS. SYMPTOMS: UNINTENDED WEIGHT LOSS COUGH WITH PHLEGM. REF REPORT: MW5151072.