FDA Adverse Event Injury Summary report: N

SYBRONPRO XRT

MDR report key: 1740960 · Received June 29, 2010

Report

Report Number
2016150-2010-00096
Event Type
Injury
Date Received
June 29, 2010
Date of Event
April 21, 2010
Report Date
June 22, 2010
Manufacturer
EBI INC.
Product Code
DZE
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
US
Reporter Occupation
DENTIST

Narratives

Description of Event or Problem · 1

ON JUNE 22, 2010, A DOCTOR REPORTED THAT A PATIENT LOST A SYBRONPRO XRT IMPLANT SIX (6) MONTHS AFTER PLACEMENT DUE TO UNKNOWN CAUSES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SYBRONPRO XRT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE EBI INC. 091110/093119

Patients

Seq Age Sex Outcome Treatment
1 49 YR Other| R