FDA.reportPublic FDA data

MAUDE MDR 8353131

MDR report key
8353131
Report number
3003933619-2018-00009
Event key
0
Event type
3
Date of event
2018-10-15
Date received
2019-02-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

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

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PIEZOSURGERYMT1-10, INSERT FOR GENERAL BONE SURGERYMECTRON S.P.A.JDXMT1-100360000118002205Y R

Patients#

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

Event Narratives#

N

Patient 1

THE MANUFACTURER MECTRON S.P.A. RECEIVED THE INSERT INVOLVED IN THE EVENT. AN INVESTIGATION WAS CARRY OUT BY THE MANUFACTURER: THE INSERT RETURNED, MT1-10, LOT. NUMBER 18002205, WAS ANALYSED BY AN EXTERNAL LABORATORY. THE RESULT OF THIS ANALYSIS DIDN'T REVEAL ANY CRITICAL PROBLEM ON THE STRUCTURE OF THE INSERT. MOREOVER THE DESIGN, PRODUCTION, IN-PROCESS AND FINAL CONTROLS DOCUMENTS, RELATED TO THE INSERT MT1-10, LOT 18002205 DIDN'T SHOW ANY ANOMALY.

D

Patient 1

DURING THE USE IN A MAXILLOFACIAL SURGERY, THE INSERT MT1-10, LOT N. 18002205, EXPIRATION DATE 30 JULY 2023, ETO STERILIZATION BATCH (B)(4), BROKE. NO ADVERSE EVENT OCCURRED TO THE PATIENT.