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

Catalog Number	AR-13370-3
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received from arthrex, inc., including their medical device report, initial report, and follow-up reports, the complaint allegation regarding breakage of screws was confirmed, and it was concluded that the most likely cause of the reported failure was attributable to a patient-specific factor.Three (3) "osferion" (ar-13370-3) manufactured by our company were used as a bone void filler and were not load-bearing fixation devices.There was no evidence reported indicating breakage, malfunction, or performance failure of osferion.At this time, there is no information available to suggest that our device may have caused or contributed to the reported event.We received the information from arthrex, inc., on april 16, 2026.This report is being submitted to fda to document that our company became aware of the adverse event involving the use of our device in conjunction with other manufacturers' fixation components.
Event or Problem Description
Based on information provided by arthrex, inc., it was reported that during a high tibial osteotomy procedure, arthrex, inc.-manufactured cortical screws were found broken during a post-operative follow-up.The patient did not have any significant complaints and did not recall any event or injury to have occurred.A collapse was noticed at the patient's osteotomy site.Three (3) ar-13370-3 "osferion" (osteotomy wedges) manufactured by our company were also implanted during the same procedure.Revision surgery was subsequently performed, during which the broken screws and associated implanted components, including the three (3) ar-13370-3 "osferion" (osteotomy wedges), were explanted.The original procedure occurred on (b)(6) 2023, and revision surgery occurred on (b)(6) 2023.Both the initial procedure and the revision surgery were performed at the same facility by the same surgeon.According to the information received, post-operative x-ray images were reviewed as part of the evaluation by arthrex, inc., and based on the information available, the event was concluded to be most likely attributable to a patient-specific factor.

• Brand Name: OSFERION
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): OSFERIONBIOMATERIALS CORP. MISHIMA FACTORY; 454-1 higashino,nagaizumi-cho; sunto-gun; shizuoka, 411-0 931; JA 411-0931
• Manufacturer (Section G): OSFERIONBIOMATERIALS CORP.; 1-50-1 sasazuka,shibuya-ku; tokyo, 151-0 073; JA 151-0073
• Manufacturer Contact: yasuyo nagano ; 1-50-1 sasazuka,shibuya-ku; tokyo, 151-0-073 ; JA 151-0073
• MDR Report Key: 25012000
• Report Number: 3007738819-2026-00003
• Device Sequence Number: 18715975
• Product Code: MQV
• UDI-Device Identifier: 04560245656906
• UDI-Public: 04560245656906
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: AR-13370-3
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown