FDA.reportPublic FDA data

MAUDE MDR 8353024

MDR report key
8353024
Report number
3003933619-2018-00007
Event key
0
Event type
3
Date of event
2018-10-10
Date received
2019-02-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS GIOVANNA ROMEO
Address
VIA LORETO 15/A / CARASCO, GENOA 16042 IT
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PIEZOSURGERYMT1-10MECTRON S.P.A.JDXMT1-100360000118002348Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-200

Event Narratives#

N

Patient 1

MANUFACTURER MECTRON (B)(4) RECEIVED THE INSERT INVOLVED IN THE EVENT OCCURRED. AN INVESTIGATION WAS CARRY OUT BY THE MANUFACTURER: THE INSERT MT1-10, LOT NUMBER 18002348, WAS ANALYZED BY AN EXTERNAL LABORATORY. THE RESULT OF THIS ANALYSIS DIDN'T REVEAL ANY CRITICAL PROBLEM ON THE STRUCTURE OF THE INSERT; MOREOVER THE DESIGN, THE PRODUCTION, IN -PROCESS AND FINAL CONTROLS DOCUMENTS, RELATED TO THE INSERTS MT1-10, LOT NUMBER 18002348, DIDN'T SHOW ANY ANOMALY.

D

Patient 1

THE INSERT WAS BROKEN DURING A MAXILLOFACIAL SURGERY.