FDA Adverse Event Injury Summary report: N

OSFERION

MDR report key: 7581296 · Received June 8, 2018

Report

Report Number: 3007738819-2018-00010
Event Type: Injury
Date Received: June 8, 2018
Report Date: May 17, 2018
Manufacturer: OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY
Product Code: MQV
PMA / PMN Number: K080065
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

BECAUSE THIS PRODUCT(REFERENCED IN THIS REPORT) WAS NOT RETURNED OT OLYMPUS TERUMO BIOMATERIALS CORP. FOR EVALUATION, THE CAUSE OF THE ADVERSE EVENT HAS NOT BEEN SPECIFIED. THE OSFERION BONE VOID FILLER PACKAGE INSERT STATUS IN THE FOLLOWING SECTION: INSTRUCTION FOR USE: 1. SELECT THE SIZE AND SHAPE ACCORDING TO THE PATIENT'S CONDITION AND THE LOCATION OF BONY VOIDS OR GAPS. WARNING AND PRECAUTION: IMPORTANT BASIC PRECAUTIONS- THE (1)PORTION OF OSFERION THAT IS DROPPED INTO FOR EXAMPLE, SOFT TISSUE OR ARTICULAR SPACE SHOULD BE REMOVED AS SOON AS POSSIBLE BY USING TWEEZERS, SUCTION, OR OTHER MEANS. (4)IF NECESSARY, THE FRACTURE SHOULD BE STABILIZED USING EXTERNAL OR INTERNAL FIXATIONS TO PREVENT POST-IMPLANTATION MIGRATION OR EXTRUSION OF THE OSFERION DUE TO LOOSENING. ADVERSE EVENTS: FEVER,PAIN,LOCAL SENSATION,RED FLARE,INFLAMMATION. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IS AN ABUNDANCE OF CAUTION.

Description of Event or Problem · 1

THERE WAS ONE FURTHER OPERATION SIX MONTHS AFTER THE INDEX PROCEDURE IN A PATIENT IN WHOM THE TRICALCIUM PHOSPHATE(THIS PRODUCT) PROTRUDED FROM THE OSTEOTOMY SITE AND PRODUCED LOCAL PAIN. RECOVER WAS UNEVENTFUL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
424822	OSFERION	FILLER, BONE VOID, CALCIUM COMPOUND	MQV	OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R