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

Catalog Number 60A4

Device Problems Collapse (1099); Positioning Problem (3009)

Patient Problems Bone Fracture(s) (1870); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed, and no irregularities were noted.We suppose that this event was caused by the plate was positioned closer to the front of the tibia and the plate would have been unable to withstand the loads.Because the device(referenced in this report) was not returned to olympus terumo biomaterials corp.For evaluation, the cause of the adverse event have not been specified.The osferion bone void filler package insert states in the following section: 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

Case: a patient treated with high tibial osteotomy (hto) a patient underwent high tibial osteotomy (hto).During the operation, the surgeon in charge of the patient fixed the osteotomized tibia with a set of a metal plate and bone screws for internal fixation and grafted a piece of this product (bone void filler) trimmed corresponding to the shape of the bone defect.Afterwards, however, this product collapsed, leading to correction loss.Thus, the surgeon carried out re-operative surgery.(according to the surgeon, the metal plate and the bone screws used for internal fixation were intact) comments of the surgeon there would be no causal relationship between this event and the medical devices including this product and the metal plate and bone screws used for the internal fixation.After the first operation, i noticed a longitudinal fracture line reaching the joint surface of tibia.Considering this condition, i suppose that this event is attributable to unfavorable plate positioning.In more detail, the plate was positioned closer to the front of the tibia than i had thought.Thus, the plate would have been unable to withstand the loads.

• 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.; shinjuku monolith,; 3-1nishi-shinjuku,2-chome; shinjuku-ku,tokyo, 163-0 914; JA 163-0914
• Manufacturer Contact: jiro hirai ; shinjuku monolith; 3-1nishi-shinjuku,2-chome; shinjuku-ku,tokyo, 163-0-914 ; JA 163-0914 ; 69019264
• MDR Report Key: 5305100
• MDR Text Key: 33719738
• Report Number: 3007738819-2015-00021
• 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: 11/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 60A4
• Device Lot Number: M15613B672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2015
• 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; Required Intervention