FDA Adverse Event Injury Summary report: N

ABUTMENT: SHOULDERED 2MM INTEGRAL 3.25

MDR report key: 43623 · Received October 22, 1996

Report

Report Number
2023141-1996-00174
Event Type
Injury
Date Received
October 22, 1996
Date of Event
September 18, 1996
Report Date
September 25, 1996
Manufacturer
CALCITEK
Product Code
DZE
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
DENTIST

Narratives

Description of Event or Problem · 1

AN ABUTMENT BROKE IN FUNCTION. PT IS REPORTEDLY FINE. PT IS SAME PT AS MEDWATCH REPORT #2023141-1996-000173.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ABUTMENT: SHOULDERED 2MM INTEGRAL 3.25 Implant SCREW RETAINED DENTAL ABUTMENT DZE CALCITEK NA 961339

Patients

Seq Age Sex Outcome Treatment
1 46 YR Required Intervention