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

Catalog Number 60MA4

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Type  Injury  

Event Description

A patient underwent around the knee osteotomy (ako).The surgeon in charge of the patient fixed the osteotomized bone with a bone plate and bone screws and filled the space created after the osteotomy with this product (bone void filler).Since the patient complained of a pain in the patient's affected lower limb after the ako, the surgeon chose to slow the pace of post-operative rehabilitation and monitor the progress of the patient carefully.About three months after the ako, the surgeon detected plate breakage and nonunion and decided to carry out reoperation.During the reoperation, the surgeon freshened the fracture ends, implanted a different artificial bone, and then fixed the osteotomized bone anew with a different bone plate and bone screws dedicated to the bone plate.

Manufacturer Narrative

The device history record was reviewed, and no irregularities were noted.The plate 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: 1.Important basic precautions (3)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.(4) 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.

• 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: 18611108
• MDR Text Key: 334141609
• Report Number: 3007738819-2024-00001
• 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 Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 60MA4
• Device Lot Number: M22Z06D447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• 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
• Patient Sex: Male
• Patient Weight: 88 KG