FDA Adverse Event Malfunction Summary report: N

SUBSTITUT OSSEUX SYNTHETIQUE EUROBONE 2 STD

MDR report key: 4962037 · Received July 31, 2015

Report

Report Number: 3006761298-2015-00001
Event Type: Malfunction
Date Received: July 31, 2015
Report Date: May 7, 2015
Manufacturer: GRAFTYS
Product Code: MQV
PMA / PMN Number: K093343
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

OUR (B)(4) DISTRIBUTOR SOLD THESE PRODUCTS ON A NON AUTHORIZED TERRITORY. THE RELATED MEDICAL DEVICE IS NOT SOLD UNDER THIS TRADE NAME IN THE USA BUT WE HAVE A SIMILAR PRODUCT "GRAFTYS QUICKSET" THAT IS 510(K) CLEARED. ON THE 03/20/2015, WE SENT AN EMAIL TO THIS DISTRIBUTOR TO REQUEST THE IMMEDIATE STOP OF THE SELLING OF THESE PRODUCTS OUTSIDE (B)(6) BECAUSE THE IFU IS ONLY IN (B)(6). WE ARE AWARE SINCE THE 04/24/2015 THAT (B)(4) UNITS ARE STILL ON THE PORTUGUESE MARKET: 1 AT A SUBDISTRIBUTOR FACILITY AND 4 AT 3 DIFFERENT HEALTH CARE FACILITIES. WE'VE DECIDED ON THE 04/24/2015 TO LAUNCH A RECALL OF THESE UNITS IN (B)(6). THE PRODUCTS ARE ALL RETURNED TO THE MFR ON MAY 5TH, 2015.

Description of Event or Problem · 1

THE PRODUCTS MANUFACTURED SINCE 01/01/2014 HAVE THE IFU AVAILABLE ONLY IN (B)(6). THESE PRODUCTS WERE SOLD BY ONE OF OUR DISTRIBUTOR OUTSIDE (B)(6) BUT IN (B)(6) WITHOUT OUR PERMISSION (THE COMMERCIAL CONTRACT STATES THE SELLING OF THIS TYPE OF PRODUCTS ONLY IN (B)(6). WE IDENTIFIED A RISK OF AN INCIDENT FOR THE PT/USER BECAUSE THERE IS A RISK THAT THE SURGEON DOESN'T FOLLOW THE IFU BECAUSE HE DOESN'T UNDERSTAND IT. WE DIDN'T RECEIVE SO FAR ANY NOTIFICATION OF AN EFFECTIVE INCIDENT FROM HOSPITALS POTENTIALLY CONCERNED BY THE SITUATION. THIS PROBLEM OCCURRED IN (B)(6) AND 5 PRODUCTS HAVE BEEN RECALLED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
502350	SUBSTITUT OSSEUX SYNTHETIQUE EUROBONE 2 STD	GRAFTYS QUICKSET	MQV	GRAFTYS	263666

Patients

Seq	Age	Sex	Outcome	Treatment
1