FDA Adverse Event Injury Summary report: N

SYBRONPRO XRT

MDR report key: 2110043 · Received June 1, 2011

Report

Report Number
2016150-2011-00124
Event Type
Injury
Date Received
June 1, 2011
Date of Event
December 28, 2010
Report Date
May 16, 2011
Manufacturer
EBI INC.
Product Code
DZE
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
NV, US
Reporter Occupation
DENTIST

Narratives

Description of Event or Problem · 1

ON (B)(6) 2011 A DOCTOR ALLEGED THAT A PATIENT LOST A SYBRONPRO XRT IMPLANT APPROXIMATELY FOUR (4) MONTHS AFTER PLACEMENT DUE TO UNKNOW CAUSES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SYBRONPRO XRT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE EBI INC. 091033/092022

Patients

Seq Age Sex Outcome Treatment
1 56 YR Congenital Anomaly| O| R