MAUDE Adverse Event Report: ABYRX, INC MONTAGE SETTABLE RESORBABLE HEMOSTATIC BONE PUTTY

Catalog Number	OS-MON-1604
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	10/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Communication was received from sales agent concerning a possible infection in a comminuted trimalleolar ankle orif procedure where montage was used and hardware was placed.Other patient contacting surgical materials used during the procedure were not permanently implanted.The surgeon reported that the surgery was performed on (b)(6) 2021 and the incisions and surgical site initially healed without complication.On 10/7/2021, the surgeon contacted the sales agent and informed him the patient presented that week with an infection.Preliminary cultures were performed and species were identified as clostridium and bacillus genii; no further bacterial classification were provided.No irregularities for the montage device were noted during the procedure, use was performed in accordance with the instructions for use.A review of the batch record for the lot used in this procedure was performed and no irregularities or nonconformances were noted, including all aspects regarding sterilization.No other complaints have been received for this lot.No connection between historical device bioburden for the terminally sterilized device and identified cultures was identified.The source of the infection cannot be determined with certainty.Abyrx has requested updates concerning the patient's condition and will revise the complaint file if any additional information is received.
Event or Problem Description
Abyrx received communication from sales agent concerning a post-operative (10 weeks) infection following a comminuted trimalleolar ankle orif procedure in which montage was used and hardware was implanted.

• Brand Name: MONTAGE SETTABLE RESORBABLE HEMOSTATIC BONE PUTTY
• Common Device Name: MONTAGE SETTABLE RESORBABLE HEMOSTATIC BONE PUTTY
• Manufacturer (Section D): ABYRX, INC; 1 bridge st; suite 121; irvington NY 10533
• MDR Report Key: 12748634
• Report Number: 3005972619-2021-00001
• Device Sequence Number: 19199345
• Product Code: MTJ
• UDI-Device Identifier: 00850391007177
• UDI-Public: 0100850391007177172304301010731
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2021

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 Expiration Date: 04/30/2023
• Device Catalogue Number: OS-MON-1604
• Device Lot Number: 10731
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other