MAUDE Adverse Event Report: OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY OSFERION

Catalog Number 60A4

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed, and no irregularities were noted.Because the device (referenced in this report) was not returned to olympus terumo biomaterials corp.For evaluation, the cause of the adverse event have not been specified.The osferion bone void filler package insert states in the following section: adverse events: 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 case treated with high tibial osteotomy (hto) during the operation: after osteotomizing the tibia, the surgeon in charge of the patient implanted a bone void filler (hereafter, this product), which was trimmed corresponding to the shape of the bone defect, and then fixed the osteotomized tibia with a metal plate and screws all of which are exclusively used for internal fixation.After the operation: when removing the surgical drain 24 hours after the surgery, the surgeon observed discharge of exudate from the drain hole.The surgeon stopped the exudate by applying compression force around the drain hole to forcibly eliminate the exudate.Postoperative course: the patient has not manifested any symptoms of infection such as redness and swelling.

• Brand Name: OSFERION
• Manufacturer (Section D): OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY; 4541 higashino nagaizumicho; suntogun, shizuoka 411-0 931; JA 411-0931
• Manufacturer (Section G): OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY; 4541 higashino nagaizumicho; suntogun, shizuoka 411-0 931; JA 411-0931
• Manufacturer Contact: jiro hirari ; 3-1 nishi-shinjuku 2-chome; shinjuku-ku, tokyo 163-0-914 ; JA 163-0914 ; 69019264
• MDR Report Key: 4995767
• MDR Text Key: 22830663
• Report Number: 3007738819-2015-00010
• 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
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Catalogue Number: 60A4
• Device Lot Number: M14Z14B557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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
• Patient Age: 65 YR