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.