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

Catalog Number 60A3

Device Problems Break (1069); Collapse (1099); Device Slipped (1584)

Patient Problem Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed, and no irregularities were noted.The back-out of the bone screw in this case was probably caused by the excessive force applied to the position of the screw and the plate.We concluded that the quality of this product has no relation to this event.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.This report is being submitted as a medical device report is an abundance of caution.

Event Description

A patient underwent high tibial osteotomy (hto).During the operation, the surgeon in charge of the patient fixed the osteotomized tibia with a bone plate and bone screws for use in internal body fixation and implanted an bone void filler(this product) into the bone defect formed after the osteotomy.The surgeon confirmed bone resorption around this product about three months after the surgery.In x-ray images taken about five months after the surgery, however, the surgeon found that the posterior part of this product had collapsed.The surgeon also confirmed back-out of the bone screw inserted into the hole d of the bone plate as well as lateral hinge breakage.The patient complained of having a sense of protrusion at the hole d of the bone plate when the patient visited the surgeon for the follow-up examination about 11 months after the surgery.At that point, the surgeon confirmed that bone union had been achieved.The surgeon is closely monitoring the patient's postoperative progress.

• 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, ; 57383961
• MDR Report Key: 6606999
• MDR Text Key: 76494195
• Report Number: 3007738819-2017-00010
• 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: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 60A3
• Device Lot Number: M15801B712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2017
• Initial Date FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2015
• 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): Required Intervention
• Patient Age: 53 YR