FDA Adverse Event Other Summary report: N

O BUTMENT

MDR report key: 59661 · Received December 26, 1996

Report

Report Number
1627417-1996-90005
Event Type
Other
Date Received
December 26, 1996
Date of Event
June 20, 1996
Report Date
December 18, 1996
Manufacturer
"O" CO, INC.
Product Code
DZE
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA
Reporter Occupation
INVALID DATA

Narratives

Description of Event or Problem · 1

PT HAD A COMBINATION OF FACTORS THAT COULD HAVE LEAD TO IMPLANT FAILURE SUCH AS SMOKING, POOR ORAL HYGIENE & HE WORKED IN A TOXIC ENVIRONMENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 O BUTMENT Implant DENTAL IMPLANT DZE "O" CO, INC. TWO IMPLANTS 1774,1770,1773

Patients

Seq Age Sex Outcome Treatment
1 59 YR Other