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

Catalog Number AR-13370-1

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/24/2017

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed, and no irregularities were noted.The bone fracture in this case was probably caused by the excessive force applied to the application site.We concluded that the quality of this product has no relation to this event.Warning and precaution: important basic precautions; when load bearing capacity has been weakened or reduced due to fractures, etc., osferion should only be used if the bone can be reliably immobilized by using external or internal fixations etc.Otherwise, compaction of fractures may occur.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.This report is being submitted as a medical device report is an abundance of caution.

Event Description

On (b)(6) 2017, the patient underwent a distal femoral osteotomy procedure where a bone plate, bone screws, a bone void filler (hereafter, this product) and another bone void filler were implanted into the patient's femur.During the procedure, an ap x-ray was taken with no indications of any abnormalities.On (b)(6) 2017, the patient came in for a post-op check-up where a lateral x-ray was taken showing a fracture in the patient's femur.The patient has not experienced any pain or discomfort.The surgeon is going to keep the patient non-weight bearing for a few more weeks.

• 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; tokyo, 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: 7005269
• MDR Text Key: 91185473
• Report Number: 3007738819-2017-00016
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/24/2017

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: 12/31/2021
• Device Catalogue Number: AR-13370-1
• Device Lot Number: M16906P016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2017
• 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