MAUDE Adverse Event Report: ABYRX, INC. MONTAGE FLOWABLE SETTABLE BONE PASTE; Wax, bone

Model Number OS-MON-1501FL

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Discomfort (2330); Implant Pain (4561)

Event Date 01/26/2024

Event Type  Injury  

Manufacturer Narrative

Abyrx has received a report of a complaint related to the use of montage flowable in a podiatric surgical procedure.It was reported that the surgeon implanted the material in a bone defect and prior to hardening, began closure of the overlying soft tissue, which caused some of the implant material to migrate into the soft tissue space.The clinician asked the local representative if the material needed to be removed from the soft tissue prior to surgical closure, and according to the clinician, the representative stated that it did not need to be removed.Not removing excess material from the application site and implanting in tissue other than bone is contrary to the ifu.A review of the manufacturing records and an inspection of a retention unit did not uncover any discrepancies or nonconformities.The lot was produced according to all specifications, and no other complaints have been received for this lot.At this time no additional complaint information has been provided concerning patient condition or whether any secondary surgery/removal is required.Abyrx will update as additional information becomes available.

Event Description

Abyrx has received notification concerning an adverse event in a patient where the treatment included the use of montage flowable by a podiatrist.During the surgical procedure the podiatrist did not remove the excess material that was placed in soft tissue, contrary to the instructions for use.In the weeks following surgery the patient reported discomfort in their foot in the area that montage flowable was used.

• Brand Name: MONTAGE FLOWABLE SETTABLE BONE PASTE
• Type of Device: Wax, bone
• Manufacturer (Section D): ABYRX, INC.; 700 fairfield ave; suite 1; stamford CT 06902
• Manufacturer (Section G): ABYRX, INC; 700 fairfield ave; suite 1; stamford CT 06902
• Manufacturer Contact: alyssa mcdermott ; 700 fairfield ave; suite 1; stamford, CT 06902
• MDR Report Key: 18742438
• MDR Text Key: 335812317
• Report Number: 3005972619-2024-00002
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: OS-MON-1501FL
• Device Catalogue Number: OS-MON-1501FL
• Device Lot Number: 20077
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2023
• 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): Other