FDA Adverse Event Other Summary report: N

OSFERION

MDR report key: 2820829 · Received October 29, 2012

Report

Report Number: 3007738819-2012-00007
Event Type: Other
Date Received: October 29, 2012
Report Date: October 1, 2012
Manufacturer: OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY
Product Code: MQV
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS TERUMO (B)(4). FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO IRREGULARITIES WERE NOTED. THE OSFERION BONE VOID FILLER PACKAGE INSERT STATES IN THE ADVERSE EVENTS SECTION: INFECTION, NONUNION, FRACTURE, FEVER, PAIN, LOCAL SENSATION, RED FLARE, INFLAMMATION. POSSIBLE ADVERSE EVENTS INCLUDE BUT ARE NO LIMITED TO: SUPERFICIAL WOUND INFECTION, DEEP WOUND INFECTION, WOUND DEHISCENCE, DELAYED UNION, MALUNION, LOSS OF REDUCTION, CYST RECURRENCE, HEMATOMA, CELLULITIS, CONGLUTINATE FAILURE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IS AN ABUNDANCE OF CAUTION. PRODUCT LOT NUMBER (EXPIRATION DATE (MM/YYYY), (B)(4) (08/2016).

Description of Event or Problem · 1

THE PRODUCT WAS USED IN COMBINATION WITH LOCAL BONE FOR SCOLIOSIS SURGERY. METAL FIXATIONS MANUFACTURED BY SYNTHES WERE ALSO USED. POST-OPERATIVE FEVER WAS PROLONGED WITHOUT REMISSION AND A REOPERATIVE SURGERY WAS PERFORMED. SUPPURATION WAS CONFIRMED AT THE SURGICAL SITE WHERE THE PRODUCT WAS IMPLANTED, THEREFORE, DEBRIDEMENT WAS PERFORMED AND THE SITE WAS IMPLANTED WITH LOCAL BONE AND THE PRODUCT NEWLY OPENED. THE PYRETOLYSIS WAS OBSERVED AND THE FAVORABLE RECOVERY WAS OBTAINED. THE PRIMARY PHYSICIAN DID NOT CONSIDER THE OSFERION CAUSED THE PATIENT'S OUTCOME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OSFERION		MQV	OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY	OSFERION	M18042A782

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R