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

Catalog Number G4-2

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

Patient Problem Skin Discoloration (2074)

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed, and no irregularities were noted.Therefore, it is not considered to be a problem in product specifications.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 patient underwent high tibial osteotomy (hto) with a bone plate, bone screws and this product (bone void filler).Pigmentation was observed after surgery.

• 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: 11927477
• MDR Text Key: 253997455
• Report Number: 3007738819-2021-00025
• 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: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: G4-2
• Device Lot Number: M18Y02C532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2019
• 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): Other