FDA Adverse Event Injury Summary report: N

SST 4X13 HA CYLINDER

MDR report key: 35929 · Received August 26, 1996

Report

Report Number
2184002-1996-00155
Event Type
Injury
Date Received
August 26, 1996
Date of Event
February 29, 1996
Report Date
August 26, 1996
Manufacturer
LIFECORE BIOMEDICAL, INC.
Product Code
DZE
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
DENTIST

Narratives

Description of Event or Problem · 1

IMPLANT WAS PLACED ON 12/3/92. BRIDGE CAME OFF AND IMPLANT WITH IT, AFTER SEVERAL ATTEMPTS TO SAVE IT. THE MAXILLARY IMPLANTS, #13 AND #14, HAVE NOT BEEN UNCOVERED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SST 4X13 HA CYLINDER Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. 411020-40-13 UNK

Patients

Seq Age Sex Outcome Treatment
1 54 YR Required Intervention