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 Inflammation (1932)

Event Date 03/04/2024

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed, and no irregularities were noted.Analysis of the metal fragment determined that it was aluminum.It is assumed that soft tissue damage occurred due to handling of surgical instruments.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: 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 around the knee osteotomy (ako).The surgeon in charge of the patient fixed the osteotomized bone with a bone plate and bone screws (hereafter, metal implants) and filled the space created after the osteotomy with this product (artificial bone).The surgeon closed the surgical wound and finished the ako.However, when removing the patient from the operating room, the surgeon noticed that the surgical site was swollen.Suspecting that the swelling was caused by bleeding, the surgeon opened the surgical wound again and carried out reoperation.Although carefully checking the surgical wound, tissues surrounding the metal implants, and osteotomized bone, the surgeon was unable to identify the bleeding point.The surgeon then attempted to identify the bleeding point with vascular ultrasound and angiography, but even examination using those diagnostic tools failed to detect the bleeding point.Since a sign of blood flow impairment was observed in the region distal to the surgical site, the surgeon carried out leg vascular bypass surgery and completed the reoperation.The surgeon left the metal implants placed during the ako as they were without replacing them with different metal implants.Note: during the reoperation, the surgeon found an about 1 mm-size foreign body at the site likely responsible for the bleeding.According to the surgeon, the foreign body seemed like a metal fragment.The surgeon removed the foreign body to identify what it is.

• 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: 18984380
• MDR Text Key: 338659341
• Report Number: 3007738819-2024-00002
• 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: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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: M23706D598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/24/2023
• 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: 49 YR
• Patient Sex: Female