MAUDE Adverse Event Report: OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY OSFERION; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number OSFERION

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed, and no irregularities were noted.Meanwhile, we cannot rule out the possibility that this event was caused by either other intraoperative factors or other factors related to postoperative management.Because this product (referenced in this report) was not returned to olympus (b)(4) for evaluation, the cause of the adverse event has not been specified.The osferion bone void filler package insert states in the following section: adverse events: infection; fever,pain,local sensation,red flare,inflammation.This report is being submitted as a medical device report is an abundance of caution.

Event Description

A patient underwent high tibial osteotomy (hto).During the surgery, the surgeon in charge of the patient fixed the osteotomized tibia with a metal plate and bone screws and implanted this product (bone void filler) into the bone defect formed after the osteotomy.After the surgery, however, the surgeon confirmed that the patient was developing a surgical site infection.The patient therefore underwent debridement of necrotic tissue and wound irrigation.Comments of the surgeon: since no symptom of infection was observed in the patient's knee joint, the surgeon hastened to carry out debridement of necrotic tissue and wound irrigation.The surgeon assume that an additional surgery would be necessary to remove the plate and screws in the near future.This product would not be an immediate cause of this adverse event.

• Brand Name: OSFERION
• Type of Device: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY; 454-1 higashino,nagaizumi-cho; sunto-gun; shizuoka, 411-0 931; JA 411-0931
• Manufacturer (Section G): OLYMPUS TERUMO BIOMATERIALS CORP.; 1-50-1 sasazuka,shibuya-ku; 151-0 073; JA 151-0073
• Manufacturer Contact: jiro hirai ; 1-50-1 sasazuka,shibuya-ku; tokyo, 151-0-073 ; JA 151-0073 ; 57383961
• MDR Report Key: 6088178
• MDR Text Key: 59456908
• Report Number: 3007738819-2016-00006
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: OSFERION
• Device Catalogue Number: 60A5
• Device Lot Number: M15X04B747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention