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

Catalog Number 60A4

Device Problems Break (1069); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed, and no irregularities were noted.The plate and screws breakage in this case probably caused by the excessive force applied to the position of the plate and screws.We concluded that the quality of this product has no relation to this event.The osferion bone void filler package insert status in the following section: 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.Adverse events: fracture 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 lateral open wedge distal femoral osteotomy (lowdfo) for the patient's right lower limb.The surgeon in charge of the patient fixed the osteotomized femur with a medial distal femur plate (hereafter, bone plate), screws dedicated to the bone plate (hereafter, bone screws), and the cortical screw , and implanted an artificial bone void filler (this product) into the bone defect formed after the osteotomy.With the aim of inserting the cortical screw (4.5mm in diameter) from anterior to posterior into the osteotomized femur, the surgeon did not place a bone screw into the bone plate hole no.1 in order to prevent cortical screw and bone screw from interfering with each other.Despite right lowdfo, the surgeon applied a bone plate designed for the left femur to the affected right femur, because a bone plate designed for the right femur did not fit well on the surface of the osteotomized right femur.About six months after the operation, the surgeon found bone plate breakage.The patient was subjected to reoperation.

• 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
• MDR Report Key: 10342163
• MDR Text Key: 207895202
• Report Number: 3007738819-2020-00006
• 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: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 60A4
• Device Lot Number: M19903C669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention