FDA Adverse Event Injury Summary report: N

SYBRONPRO XRT

MDR report key: 1852588 · Received October 4, 2010

Report

Report Number
2016150-2010-00163
Event Type
Injury
Date Received
October 4, 2010
Date of Event
July 12, 2010
Report Date
September 15, 2010
Manufacturer
EBI INC.
Product Code
DZE
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
IN, US
Reporter Occupation
DENTIST

Narratives

Description of Event or Problem · 1

ON (B)(6) 2010 A DOCTOR REPORTED THAT A PATIENT LOST A SYBRONPRO XRT IMPLANT THREE (3) MONTHS AFTER PLACEMENT DUE TO UNKNOWN CAUSES. THIS IS THE FIRST OF TWO REPORTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SYBRONPRO XRT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE EBI INC. 091042

Patients

Seq Age Sex Outcome Treatment
1 70 YR Other| R