DENTAL IMPLANT TITANIUM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-20 for DENTAL IMPLANT TITANIUM manufactured by .

Event Text Entries

[80998262] I had to have a tooth in my lower jaw, front left side, removed due to it being cracked. My dentist suggested a titanium dental implant. Everything was fine with the implant until i received the crown. Literally, the next day, i developed a ringing in my left ear. It has not stopped since. I have decided to leave the implant there for now, but if it doesn't stop, i will have to have it removed. Unfortunately, within about 2 months, my right ear developed tinnitus periodically. My hearing has always been excellent, until now.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5071173
MDR Report Key6736537
Date Received2017-07-20
Date of Report2017-07-20
Date of Event2017-01-03
Date Added to Maude2017-07-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDENTAL IMPLANT TITANIUM
Generic NameDENTAL IMPLANT TITANIUM
Product CodeELJ
Date Received2017-07-20
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2017-07-20

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