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

Catalog Number OS-MON-1604

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

Patient Problem Bacterial Infection (1735)

Event Date 10/07/2021

Event Type  Injury  

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 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
• Type of Device: MONTAGE SETTABLE RESORBABLE HEMOSTATIC BONE PUTTY
• Manufacturer (Section D): ABYRX, INC; 1 bridge st; suite 121; irvington NY 10533
• Manufacturer (Section G): ABYRX, INC; 1 bridge st; suite 121; irvington NY 10533
• Manufacturer Contact: alyssa mcdermott ; 1 bridge st; suite 121; irvington, NY 10533 ; 9143572600
• MDR Report Key: 12748634
• MDR Text Key: 280066682
• Report Number: 3005972619-2021-00001
• Device Sequence Number: 1
• Product Code: MTJ
• UDI-Device Identifier: 00850391007177
• UDI-Public: 0100850391007177172304301010731
• Combination Product (y/n): N
• PMA/PMN Number: K141502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: OS-MON-1604
• Device Lot Number: 10731
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other